How to Survive an FDA Foreign Facility Inspection
Since 2002, the amount of FDA-regulated food imported to the United States has nearly doubled. With the implementation of FSMA well underway, expect that FDA will be increasing its inspections at foreign manufacturing facilities. When prioritizing inspections, FDA looks at a facility’s compliance history, the risk of the product manufactured in the plant, the date of its last inspection, and any import alerts associated with the site.
First and foremost, it’s important to make sure your foreign facility understands what a food safety plan under FSMA requires, said Chengboey Lau, principal scientist for North America scientific & regulatory affairs at Mondelēz International. Today at the GMA Science Forum Lau pulled from the experience of Mondelez (the $30 billion-company has more than 165 manufacturing plants worldwide and requires all of its suppliers to be GFSI certified) to provide some helpful tips on how a company can get ready for an FDA inspection of a foreign facility, what it should do during the event, and the steps that should be taken afterwards.
Prepare for the Inspection
- Develop an internal policy for foreign inspections
- To ensure readiness at all times, implement a proactive program that involves the following activities
- Annual review of registered facilities
- Review of any products or materials made for U.S. markets (including R&D samples)
- Gap assessments to ensure compliance with FDA requirements, followed by an action plan to close identified gaps
- Employee training on FDA requirements
- Create a site-specific FDA inspection manual for all necessary documentation
Survive the Inspection
- Align expectations with the inspector at the start of the inspection
- Have an employee who has strong English skills present to help with translation (the employee should have an understanding of American slang, too)
- Consider having a U.S. regulatory support colleague available for questions during the inspection
Post-inspection
- Email the inspector or make a Freedom of Information Act request if you don’t receive an establishment inspection report after six months
- If a form 483 letter is issued, respond in writing within 15 days, and follow up within 40 days to inform FDA of the completion of any corrective actions
At the end of the day, make sure you have a firm understanding of which final FSMA rules apply to your organization, advised Lau. From there companies should perform a gap analysis, identify the resources necessary and any constraints involved, train employees on the new FSMA expectations, and be prepared to implement new and/or modify current policies and procedures to ensure inspection readiness.