OIG Says FDA Recall Initiation Process Not Efficient or Effective
As a result of an ongoing audit of FDA’s food recall program, the Office of Inspector General (OIG) has concluded that FDA does not have the policies and procedures in place to ensure that voluntary food recalls are initiated in a prompt manner.
“This issue is a significant matter and requires FDA’s immediate attention,” the letter stated. “We suggest that FDA update its policies and procedures to instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.”
The audit follows a report from June 2011 that reviewed FDA’s monitoring of imported food recalls. That particular report also found the agency’s food recall program to be inadequate due to the fact that FDA did not have the authority to require companies to recall certain foods. FSMA has changed this aspect of recall authority.
The OIG’s letter, addressed to FDA Commissioner Robert Califf, M.D., specifically calls out two recall cases:
- A nut butter recall due to Salmonella in which 14 people became ill. According to the OIG, 165 days passed from the time FDA identified the adulterated product to the time the company initiated a recall.
- Several recalls of cheese products due to Listeria monocytogenes in which 9 people became ill and one infant died. In this situation, 81 days passed from the time FDA was aware of adulterated product to the time the company recalled the products.
The OIG issued the letter to Califf as an early alert. The audit of FDA’s food recall process is continuing and the OIG will be issuing a draft report at the conclusion of the audit.