-by Jack Hornickel
Earlier this week, Food Safety News reported on a Los Angeles-based seafood distributor cited in an FDA Warning Letter for deficiencies in its seafood HACCP plan. This quote from the article caught our eye:
FDA’s district office used the warning letter to express its concerns about shortcomings the agency found in the company’s response to its earlier concerns.
Food Safety News drew this conclusion from the Warning Letter itself:
We acknowledge receipt of your written response dated October 18, 2013. We have reviewed your response, which included an updated HACCP plan, as well as corresponding records. However, based on your response and your HACCP plan that was provided, your canned raw scallops and canned pasteurized crab meat continue to be adulterated.
This is a perfect example of how the FDA will ratchet-up its enforcement authority if it receives an insufficient response from a food processor during an investigation. In this case, an inadequate response to a relatively discrete inspection precipitated a public flogging in the form of this Warning Letter. This exchange demonstrates why it is so utterly important to respond accurately and comprehensively to any issues raised by regulators during an FDA inspection.
Immediately after a facility inspection, FDA must meet with the company’s manager and discuss the findings. The FDA’s Investigations Operations Manual coaches FDA inspectors to advise the company that its response to the observed violations “may impact FDA’s determination of the need for follow-up action, if FDA receives an adequate response to the [results of inspection] within 15 business days.” While nothing in the law requires an inspected company to reply, a well-crafted response is a company’s best chance of avoiding a public warning and further enforcement.
The key takeaway from all this is to have an attorney review all communication with the FDA to ensure that no statement is made during an investigation that can expose the business to additional liability. FDA has a continuum of powers it can use against food businesses. The strongest administrative actions available are mandatory recall of adulterated food, suspension of food production, and temporary seizure of food products. Communication errors at any step during an investigation could provoke the FDA to use these powers, so food businesses have plenty of reason to tread very carefully throughout an inspection.
