Tag Archives: recall

Katy Jones, Foodlogiq
FST Soapbox

Mitigating Supply Chain Risk with Transparency and Traceability

By Katy Jones
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Katy Jones, Foodlogiq

Attend the Food Safety Supply Chain Conference, June 5–6, 2017 in Rockville, MD | LEARN MOREA recent study from The Hartman Group on the topic of transparency found that consumers are becoming more concerned about imports and the safety standards behind companies producing food and beverage products beyond U.S. borders.

So with the drastic rise in consumer expectations for food quality and safety in the past few years, how can companies ensure they’re mitigating risks in the supply chain while fostering transparency to meet consumer expectations?

To our benefit, the focus of the broader food industry and the government, as well as innovations in technology, are making it easier than ever to comprehensively track the supply chain.

Another Day, Another Food Recall, Another Listeria Scare

In today’s reality, whether we like it or not, food recalls are an inevitable part of the food industry, and adulteration in the supply chain is a key safety issue. With the wellbeing of consumers at stake, if a contamination finds its way into a brand’s supply chain, the best possible course of action is to take action on a recall using impeccable supply chain records and monitor the affected product moving throughout the chain.

With recalls being here to stay in the food industry, companies need to be prepared to handle these issues quickly and effectively. By implementing supplier management and whole-chain traceability software, allergens and impurities can be pinpointed to a specific lot of product as opposed to being limited to processing/issue date, and not knowing the source or country of origin of every ingredient (as many suppliers can contribute to one product) within the supply chain.

Additionally, with these technologies, brands can keep their supply chain transparent and compliant with growing industry regulations. With consumer standards on the line, proactive transparency can ensure that a company has a plan of attack when the inevitable hits.

A Targeted and Precise Plan

Companies and brands need to broaden their definition of food safety in order to manage and satisfy an expanded set of consumer expectations. The traditional, linear “one-up and one-back” (OUOB) approach to supply chain is no longer acceptable when it comes to comprehensive supply chain transparency.

Consumers need a targeted and precise plan when dealing with the safety of their food—it’s no longer just about whether the food safe to eat. The definition has expanded to include safety around ingredients and country of origin. Awareness of where a product came from and where it is going next is not an acceptable method if a company wishes to foster transparency with customers and effectively manage recalls. In addition, these standards are emphasized by federal regulations like the FSMA and FSVP—the industry is now shifting towards preventative approaches to safety matters, as opposed to reactive. FSMA requires food manufacturers to increase focus on prevention rather than response to contamination incidents, which will require a comprehensive view of the entire supply chain.

Brands will need to develop strong food safety plans with streamlined audits and compliance records, verifying supply chain partners and executing corrective actions for suppliers that are not in compliance with the process and food safety plan set in place. In establishing this process, having the technology to support it is paramount in ensuring that suppliers are sticking to the food safety practices necessary to follow industry regulation and exceed consumer expectation.

Transparency in Today’s Complex Food Paradigm

As the global food supply continues to grow in volume and complexity, brands have an opportunity and an obligation to adapt to the food paradigm. According to a Label Insight study, 94% of consumers say transparency from food brands is the #1 factor that impacts purchase. Brands are no longer able to blame a supplier’s lack of transparency or unreliable records for exposing consumers to unsafe products but instead, the brand is solely held accountable.

Transparency and proactivity were optional in the past, but are now established as fundamental components of a brand’s safety plan if they are to adapt to the changing industry landscape as well as consumer demand. As recalls are bound to happen, proactivity and transparency can ensure that a company is one step ahead of an outbreak at all times.

The fact is, adapting to this shifting environment and aligning with these best practices and the technologies that enable them is critical to the success of the supplier, distributor and across the whole supply chain. Food companies must look to utilize big data analytics and intelligent supply chain mapping technologies in order to improve transparency and increase traceability. With the ability to track ingredients back and forth across the supply chain, these technologies enable a safer consumer experience as well as provide tremendous business value in eliminating inefficiencies, managing supply chain issues, and effectively protecting the brand with the insights offered.

Sabra hummus recall

Sabra Recalls Hummus Due to Possible Listeria Contamination

By Food Safety Tech Staff
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Sabra hummus recall

Don’t miss the Listeria Detection & Control Workshop at the 2016 Food Safety Consortium | December 7–8 | Schaumburg, IL | Learn MoreFDA has issued a consumer alert following the recall of Sabra Dipping Company’s hummus products. The agency began an inspection of Sabra’s manufacturing facility in Virginia on October 31, collecting nine environmental samples that test positive for Listeria monocytogenes; FDA collected 18 additional environmental samples near food handling equipment on November 18, which tested positive for Lm. It’s also possible that the strain of Lm found in the facility is persistent in the company’s production environment, according to FDA.

“One of the strains of Listeria monocytogenes found during the recent inspection matches a strain found in a retail product sample collected in 2015, indicating this strain of Listeria monocytogenes may be persistent in the production environment.” – FDA

Sabra initiated a voluntary recall of certain hummus products distributed in the United States and Canada with “Best Before” dates on or before January 23, 2017. “Subsequent to the inspection conducted with the FDA, we implemented a thorough and extensive factory-wide cleaning and sanitation procedure, and beyond that, we continue to work very closely with internal and external food safety experts to identify any additional steps we can take to even further enhance our efforts,” according to a Sabra press release.

Recall

More Ice Cream Recalls Over Listeria Concerns

By Food Safety Tech Staff
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Recall

The 2016 Food Safety Consortium features a Listeria Detection & Control Workshop | Don’t miss this event two day event, December 7–8 in Schaumburg, IL | LEARN MOREOver the past few days there have been at least four recalls over Listeria concerns in ice cream products. On Monday, Blue Bell Ice Cream voluntarily recalled all of the products made with a cookie dough ingredient from one of its suppliers, Aspen Hills. “Although our products in the marketplace have passed our test and hold program, which requires that finished product samples from a batch test negative for Listeria monocytogenes before the batch can be released, Blue Bell is initiating this recall out of an abundance of caution,” according to a release on FDA’s website. Other recalls include:

Similar to the Blue Bell recall, the other two recalls involving cookie dough came from the ingredient supplied by Aspen Hills, Inc.

No illnesses have been reported.

Recall

Massive Flour Recall Expanded, Again

By Food Safety Tech Staff
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Recall

As a result of four additional confirmed illnesses, General Mills has added four more production dates to its flour recall (production dates through February 10, 2016). The initial recall was announced May 31, with an expanded recall taking place earlier this month.

“At this time, it is unknown if we are experiencing a higher prevalence of E.coli in flour than normal, if this is an issue isolated to General Mills’ flour, or if this is an issue across the flour industry. The newer detection and genome sequencing tools are also possibly making a connection to flour that may have always existed at these levels,” according to a company release on FDA’s website.

Thus far, illnesses have only been linked to consumers who said they ate or handled uncooked dough or ate uncooked batter made with raw flour, not with flour that was baked, cooked or handled.

Recall

More E. Coli Illnesses, General Mills Expands Flour Recall

By Food Safety Tech Staff
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Recall

Consumers should check their pantry. As a result of newly reported illnesses connected to raw dough or batter consumption, General Mills has expanded its recall of Gold Medal flour, Wondra flour and Signature Kitchens flour to include products made last fall. The FDA and CDC have warned consumers against eating any raw products made with flour.

According to the CDC, the multi-state outbreak of Shiga toxin-producing E. Coli O121 has sickened at least 42 consumers (with 11 hospitalizations) across 21 states. No deaths have been reported. The bacteria was isolated from samples of General Mills flour that was collected from the homes of those sickened in Arizona, Colorado and Oklahoma.

General Mills has already conducted a voluntary recall of 10 million pounds of flour (unbleached, all purpose and self rising). A full list of the products included in the recall are available on FDA’s website.

Recall

More Than 358 Frozen Foods Recalled Over Listeria Concerns

By Food Safety Tech Staff
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Recall

Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MORE–UPDATE–May 5, 2016–The CDC has reported that eight people have been infected with Listeria from three states from September 2013 to March 2016. According to an FDA release, whole genome sequencing conducted from a routine product sampling program by the Ohio Department of Agriculture revealed Listeria monocytogenes (Lm) from frozen corn and that it was closely related genetically to seven bacterial isolates from those sickened. It found a similar result from frozen peas, with an Lm isolate closely related genetically to one isolate from one person. “This close genetic relationship provides additional evidence that the people in this outbreak became ill from eating frozen vegetables produced by CRF Frozen Foods,” the release stated.

In March FDA collected environmental samples from Oregon Potato Company (also located in Pasco, WA), which were found to be closely related genetically to seven isolates of sickened people linked to the outbreak. As a result Oregon Potato voluntarily recalled its wholesale onion products. “FDA is working to identify other parts of the relevant supply chain that may have product relating to this outbreak. However, FDA is prohibited by law from releasing publicly certain information about supply chains, which may constitute confidential commercial information,” according to the release.

The agency is trying to determine whether there is a connection between product sample isolates and environmental samples taken. FDA called it a “complex and ongoing investigation”.

–END UPDATE–

Pasco, Washington-based CRF Frozen Foods has expanded a nationwide voluntary recall of its frozen fruits and vegetables over concerns that the products may be contaminated with Listeria. The recall, which also includes products sold in Canada,  encompasses more than 358 consumer products sold under 42 different brands of frozen organic and traditional fruit and vegetable products that were manufactured or processed in CRF’s facility since May 2014. Seven people from at least three states have been sickened and hospitalized due to Listeria. According to an announcement on FDA’s website,  “Some of these illnesses have been linked to consuming CRF-manufactured or processed products. CDC also informed us that, sadly, two of these individuals later died, but that Listeria was not the cause of death in either person.”

CRF suspended operations at its facility in Pasco, Washington on April 25 (following the first voluntary recall) and all affected retailers have been notified.

According to the FDA announcement:

“Products include organic and non-organic broccoli, butternut squash, carrots, cauliflower, corn, edamame, green beans, Italian beans, kale, leeks, lima beans, onions, peas, pepper strips, potatoes, potato medley, root medley, spinach, sweet potatoes, various vegetable medleys, blends, and stir fry packages, blueberries, cherries, cranberries, peaches, raspberries, and strawberries.”

The full list is available on FDA’s website.

Fritz Kriete
FST Soapbox

5 Ways Food Companies Can Protect Themselves And Customers

By Fritz Kriete
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Fritz Kriete

While illnesses linked to Chipotle restaurants are grabbing headlines, the federal government recently took steps to improve how manufacturers and packagers process and handle food. Last year FDA released several final FSMA rules, giving food companies a roadmap for ensuring food safety. The proactive approach of the regulations can help companies avoid the hazards that lead to disease and allergen contaminations, and even legal troubles. Indeed, unsafe food handling can carry costly consequences from both a financial standpoint as well as in lives lost or harmed.

In 2011, the good intentions of a family-owned cantaloupe company produced tragic results. The company, seeking more natural melons, followed a consultant’s advice and discontinued the chlorine rinse used to wash off contaminants. A Listeria outbreak followed, killing 33 people and hospitalizing 147 more. Although prosecution is rare in foodborne disease outbreaks, the company owners were sentenced to probation, home detention, community service, and $150,000 each in restitution.

A more egregious case occurred in September 2015, when the former CEO of the Peanut Corporation of America was convicted of knowingly shipping Salmonella-tainted peanut butter, which had caused an outbreak that killed nine people and sickened hundreds more. Stewart Parnell was sentenced to 28 years in federal prison.

The new regulations require companies to undertake hazard analyses of their production, along with remedial steps. This scrutiny leads to the creation of a written plan that details the controls to prevent contamination and establish a schedule for periodic testing. This analysis and control system is called the Hazard Analysis Critical Control Point, or HACCP.

Adherence to regulations doesn’t necessarily protect a company from liability, but not adhering can sound a company’s death knell when there’s a problem. The following are five ways in which companies can protect themselves:

  1. Put food safety first. The company culture must revolve around it. The message that the HACCP plan is to be followed must be relayed to all levels of the organization. Otherwise, companies can face severe consequences, based on the question, “Did the company behave badly enough to face strong punitive damages?”
  2. Concentrate on internal communications. In many cases, food recalls happen because of a breakdown in the communication process.
  3. Hire accredited consultants. Make sure that your consultants are qualified and have been accredited by an appropriate body such as the International HACCP Alliance or The Seafood HACCP Alliance.
  4. Don’t overlook supplied products. Suppliers should adhere to strict contamination-prevention protocols, but don’t assume they follow guidelines completely or have flawless processes.  Your contracts with them should require that they periodically audit their facilities and share the audit results with you.
  5. Label clearly. Packaging language might state that a product is manufactured in facilities that also process allergens such as peanuts and tree nuts. These types of warnings allow consumers to make up their own minds. It is also a reminder that HACCP plans must address prevention of cross-contamination (i.e., putting cleaning protocols in place if products with and without allergens are processed on the same equipment).

Many problems involve internal slip-ups or problems with supplied ingredients that allow contaminated food to reach consumers. If the contamination becomes known—and it often is not, when victims don’t equate their illnesses with tainted food—the businesses involved often face strict liability, meaning they carry some blame even if they didn’t act in a negligent manner and cause the problem directly.

Keep in mind that liability isn’t the only consequence of non-compliance. A recall or outbreak can damage the reputation of the company and the product. The cantaloupe tragedy sent sales of the melons plummeting, even in states not linked to the outbreak.

To minimize the hit on sales, a recall team should be in place, with a plan modeled on crisis management principles. Team members should come from all divisions of the company, including transportation and distribution to track down products, and communications to manage messaging. Legal counsel should be on board to advise on the ramifications.

When it comes to foodborne outbreaks, it’s a matter of taking classic prevention and preparation steps. Do everything you can to keep it from happening, but be ready just in case it does.

Complacency Kills. What To Do Before a Recall

By Maria Fontanazza
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A control point breakdown can lead to a food safety recall. Here’s what to expect, what to do, and how to move forward. But most importantly, this discussion with Alan Baumfalk, lead auditor and technical manager for Eurofins food safety systems, will focus on prevention and re-evaluating whether your company’s current plans will be effective in the wake of a recall.

Food Safety Tech: What is the role of the crisis management plan as it relates to a company’s food safety program?

Alan Baumfalk: The crisis management plan is an interwoven topic. Some people use crisis management or business continuity interchangeably, but they tend to have a bit of a different focus.

First of all, a crisis management plan usually goes together with a food safety plan, and in some cases, it is part of a food safety plan. We are all familiar with the food safety plan, which includes a HACCP plan (Hazard Analysis and Critical Control Points). HACCP consists of seven principles. We’re all involved in HACCP everyday; it’s related to everything we do. We identify the hazards that might be involved in the food we’re producing; we identify the hazards that might be involved in our daily lives (for example, we choose no to drive in rush hour traffic because of the potential hazards that might be involved).

This all fits into our food safety program where we try to eliminate risk through risk assessment. We establish critical limits of what we will and will not accept, and then we monitor and verify them. We take corrective actions when something we monitor is not within that critical limit. Verification involves verifying that what we’re monitoring is indeed being monitored, and finally, there is record keeping.

The crisis management team wants to prevent a recall, which is a crisis to the business, to the brand, and to the health and welfare to the public. No one wants to have a recall. When putting together this plan, you need to make sure you have a multidisciplinary team. It cannot consist of all sales people, nor can it be solely quality control people. You have to bring in people with certain expertise: Include people that are from legal, media/communications, and the business group.

FST: In preparing for a crisis, where does business continuity planning fit into the picture?

Baumfalk: Crisis management has two additional components—the business continuity plan and the food defense plan. They are not exactly the same, and they are not necessarily interchangeable. The business continuity plan is related to how you are going to continue your business if you have a situation that occurs. It can be a crisis that involves a buyer, an environmental hazard, or a physical hazard, for example.

Sometimes people will consider what is happening in the media right now. What happens if there’s an incidence at the local school and your employees have children there. What are you going to do and how will you respond? How will you continue to do business in a safe way?

When putting together a business continuity plan, you need to ask yourself, how are you going to cope with the business crisis and continue doing business.

  • Designate a senior manager who is in control of handling the organization and making the necessary decisions.
  • Identify a multidisciplinary crisis management team. Each person should have a specific responsibility (i.e., medical, regulatory services, contacting customers, suppliers and internal/external communications). Each team member should be prepared to respond to food safety issues.
  • Develop a contact list that includes legal and various experts in the industry.
  • Train employees.
  • Devise a worst-case scenario and practice, practice, practice. The plan should be tested rigorously and on an annual basis.

When we talk about a mock recall, one of the biggest deficiencies is that people don’t rigorously test it. The number one priority should be to have the plans in place and test them, and identify the weaknesses that you can correct. One of the biggest problems that may eventually cause a recall is complacency. The employees think they got it all covered. It’s important to note that an ounce of prevention is worth a pound of cure.

In Part II of this series, Baumfalk will make the connection between crisis management planning and food defense.

Dr. Peyman Fatemi, Vice President of Scientific Affairs, The Acheson Group
Beltway Beat

Market Withdrawal Vs. Recall: What’s the Difference?

By Peyman Fatemi, Melanie J. Neumann
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Dr. Peyman Fatemi, Vice President of Scientific Affairs, The Acheson Group

Determining whether to initiate a market withdrawal or recall procedure depends on the situation and unfortunately, is not always a clear-cut decision. Whether due to a lack of insights into the intricacies of recall management nuances o r because you simply cannot please everyone all the time, even using the best judgment can still cause upset. Take, for example, the 2013 Chobani yogurt incident: Let’s look at some of the facts surrounding the case.

The Chobani Market Withdrawal

On August 31, 2013, Chobani initiated a market withdrawal of yogurt due to “quality concerns surrounding certain products, which were experiencing swelling or bloating.” On September 3, the company stated that the issue was caused by a type of mold “commonly found in the dairy environment”.

Although the mold (Mucor circ inelloides) was not considered to be a disease-causing foodborne microorganism and “should not pose a health risk to most consumers” (according to Chobani’s blog), the company moved from a voluntary market withd rawal of the product to a voluntary recall on September 5.

Chobani seemed to be following protocol on withdrawals and recalls, and it was providing daily updates to consumers on its blog, but it did not escape negative publicity. In fact, foodborne illness lawyer Bill Marler, who dedicated nine of his own blogs to the incident, stated, “This probably ranks near the top in a mismanaged recall/market withdraw/PR disaster that I have seen in 20 years.” And directed questions to Chobani, including: “Why did you at first try to quietly ‘withdraw’ the product instead of issuing a ‘recall?’”

Market Withdrawals vs. Recalls

So, when should you initiate a market withdrawal and when might does it need to be elevated it to a voluntary recall (and if so, at what recall class)? In addition, at what point does FDA escalate it to a mandatory recall? Or, when should you voluntarily inform FDA yourself?

Chobani’s issue was not an isolated case. There are several theories about why its recall received so much negative publicity. Was the company slow to initially respond? Could it have stayed on top of social media monitoring more proactively? Did it take too long to determine the need to elevate from a market withdrawal to a recall? Some would say yes. Others would say the company made the best decision it could with the facts it had at the time it had to make the decision. Whatever the reason—understanding the nuances between market withdrawals and recalls will help.

Since each case will be unique, there isn’t a hard-and-fast answer without discussing the particulars of each situation, but we can provide you with more information about withdrawals and recalls – so that your first reaction and call are, if nothing else, at least a bit less frantic.
FDA’s definitions:

• Market withdrawal: When a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the violation.
• Recalls: Actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
Class I: There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II: Use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
Class III: Use of or exposure to a violative product is not likely to cause adverse health consequences.

In the Chobani case, an initial assessment showed that “common mold” was a quality issue that did not violate food safety regulations or require a recall, so the company initiated a market withdrawal. However, as more people who consumed the yogurt allegedly became ill, the incident was escalated (although no confirmed link was established) and was eventually classified by FDA as a Class II recall.

Your company needs to ask this type of question when a product is found to be defective in any way. Not only which of the above definitions does it fit at this time, but also whether it is likely that the consequences could be more severe. Using Chobani as the example, perhaps the fact that containers were bulging and exploding would indicate that there was a component in the product that could potentially make people sick? You need to constantly reassess the situation and consider if a status or actions must change.

Additionally, you need to consider your brand reputation. No one really wants to go to the regulators and fess up to a mistake that may not become an issue. But, it’s kind of like telling Mom you accidentally spilled your red Kool-Aid on the carpet before she sees it. If immediately targeted, that stain just may come out – and she may even consider your scrubbing of the carpet and promise to NEVER again take red Kool-Aid into the living room as “corrective action” enough. But if it sits for a day and she finds it herself while you remain quiet, it could be permanent, her trust in you soiled, and the punishment more severe than if you would have just told her in the first place.

When in doubt, if you address the potential “stain” on your product and brand head on, admit to your error, be upfront about the cause – and what you are doing to correct it – to both FDA and your customers, FDA is likely to work with you on your situation, and your customers will forgive you and continue to buy your product once they know the issue has been corrected. Understanding the differences between market withdrawals and recalls will be key to possibly avoiding a “spill” in the first place.

Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

How the Blue Bell 483 Inspection Reports Affect Us

By Dr. David Acheson
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Dr. David Acheson is the Founder and CEO of The Acheson Group

FDA has released the 483 Inspectional Observation reports involving the Blue Bell facilities following the recent Listeria outbreaks in ice cream. While most of the information contained in a 483 is not a big surprise to a typical food safety expert, I was still struck by some of the observations. Below are extracted sections within the 483 language that raised some questions in my mind.

Point 1

“Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination… Plant Environmental Program was used as an indicator determining whether the cleaning and sanitation program was effective. However this sampli ng program failed to include the following:

  • Sampling food contact surfaces.
  • Determination of the Listeria spp. associated with the presumptive positive results.
  • Root cause analysis of why the cleaning and sanitizing treatments were inadequate in controlling the occurrences of microbiological contamination.”

Q: Does this mean that FDA expects us to do zone 1 testing on a routine basis?
A: Based on this 483 – the answer is yes. But, if so, when should this be done? Is post clean up and pre-start up adequate? I sure hope so!

Q: Does this mean whenever we identify Listeria spp. we need to get it typed to determine the type of Listeria?
A: Based on this 483, the FDA will write you up if you simply stop at Listeria spp.

Q: Does this mean that every time we have a positive finding, we must document a root cause analysis?
A: Maybe…or is it only when we have multiple positives?

Point 2

“You also stated the results of your daily total coliform sampling on finished product, in process product, and raw ingredients added post pasteurization were used as an indicator in determining whether the cleaning and sanitation program was effective. However, this sampling program failed to include the following:

  • Determination of the pathogenicity of the coliform isolates.

Q: Does this mean when we find coliforms in finished product, or in ingredients being added post lethality or with in-process product, we need to determine if any of the coliforms would be considered to be pathogens?
A: The answer would appear to be yes.

Point 3

“Failure to store cleaned and sanitized portable equipment in a location and a manner which protects food-contact surfaces from contamination.”

This observation was related to equipment that was being stored in a basement area uncovered and unprotected, and that same equipment would be re-cleaned and sanitized prior to use.

Q: If you are storing equipment that has a food-contact surface, should the food-contact surface area be fully covered and protected, even if you will clean and sanitize it prior to production?
A: Based on this observation, the answer is yes. When you store equipment you will later use and if it has a food contact surface, make sure you cover and protect that surface during storage.

Point 4

“All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, you do not have cleaning and sanitizing procedures for employee shoes worn into the sanitary food production areas of the firm to ensure that any potential contamination risks are minimized.”

Q: Does this mean that, at all entries to a sanitary or RTE area, there needs to be a process for cleaning and sanitizing footwear?
A: While this is certainly a common industry practice, it appears to now be a requirement.

Point 5

“The design of equipment does not allow proper cleaning and maintenance. Specifically wooden pallets which are porous and not easily cleanable are used throughout your firm to store and transport raw ingredients, finished product, and packaging materials. The wood pallets were observed in different stages of damage and disrepair while they were being used in the kitchen, warehouse, freezer, production, and mixing areas. The top platform, bottom, and corners of the pallets were broken, discolored, and soiled. The wood pallets were also observed to be saturated from being used in the wet processing areas and were observed as having black mold-like residues and red stains.”

Q: Is FDA declaring war on wood pallets?
A: Certainly wood pallets are known to be a potential problem, but FDA is making it clear that you should not use wood pallets if they are damaged, discolored or soiled – even to store packaging materials or containers of food that will subsequently be used in production.

Conclusion

There are always opportunities to learn from others’ 483s, however, the above 483 extractions a little alarming. Not many companies will speciate Listeria spp., they will treat a Listeria finding as though it were LM and act accordingly. But based on these 483s, FDA could issue a 483 if you don’t speciate your Listeria spp. They could issue a 483 if you don’t test your coliforms in finished product or raw ingredients being used in finished product to see if any are pathogenic.

The language in the Blue Bell 483s is sending a strong prevention message to the food industry. It is also clearly using FSMA-like approaches. I see some of the observations in these 483s as being grenades that FDA has lobbed out – and it will be interesting to see if they have pulled out the pins as FSMA continues to roll out and FDA kicks up its inspections of food safety plans and preventive controls a notch. My message to the industry is this: Watch out and learn from others’ mistakes.