Tag: investigation

FDA’s Right To Photograph In Your Plant

The FDA asserts in its inspection manual its right to photograph in your plant. Yet the FDA does not have statutory authority to photograph. The manual cites the following cases as authority for its right to photograph the inside of a plant: Dow Chem. Co. v. United States, 476 U.S. 227 (1986), and United States … Continue Reading

Learn How to Prepare for an FDA Inspection

Next Wednesday at the ACI Food Regulatory Summit in Chicago I’ll be presenting a talk entitled "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should Government Come Knocking." My slide-deck can be linked here. Topics that I plan to cover include: FDA’s plan to increase frequency of inspections … Continue Reading

Tool For Food Companies and Litigators – New Guidelines for Foodborne Disease Outbreak Response

Council to Improve Foodborne Outbreak Response (“CIFOR”) has published new guidelines designed to help local, state and federal agencies to improve their response to outbreaks. I became aware of this (again) through Ricardo Carvajal, who was a reviewer for the guidelines, and his firm’s FDA Law Blog. I agree with Ricardo that while the guidelines … Continue Reading

Update on Criminal Risk Management: The Peanut Case

Peanut Corporation of America's way of dealing with positive salmonella tests for its peanut products is a case study in exactly what not to do to avoid criminal prosecution. The FDA's investigation indicates that PCA shipped product before test results came in and then continued to ship after receiving positive tests. This is precisely the kind of actions that are likely to compound, not lessen, the likelihood of criminal prosecution. Indeed, the FBI is now involved in the case, assisting the FDA's Office of Criminal Investigations.… Continue Reading

Avoiding Criminal Prosecution Under The FFDCA

By guest blogger Per Ramfjord The FDA’s recent announcement that it is pursuing a criminal investigation of Peanut Corporation of America, arising out of the Salmonella-driven peanut product recall, is sure to raise concerns with executives in food product companies throughout the country. White House Press Secretary Robert Gibbs’s comment that the Obama administration intends … Continue Reading

What to Do When the Investigators Knock . . .

This week brought news of yet another nationwide Salmonella outbreak from a source not yet identified by government regulators. The last time we had a nationwide Salmonella outbreak for an extended period of time without identification of a definitive source the federal government initially singled out tomatoes imported from Mexico (a huge array of products). … Continue Reading
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