FDA Warning Letters

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.

Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.

A food firm in Maine is on notice from the FDA for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and for the discovery of Listeria monocytogenes in their facility.

In a Jan. 24 warning letter, the FDA described a Sept. 21-23, 27 and 30, and Oct. 6, 2021, inspection of  Greenhead Lobster Products ready-to-eat (RTE) seafood processing facility in Bucksport, ME.

The FDA’s inspection revealed that the firm was not in compliance with FDA regulations and resulted in the issuance of an FDA Form 483.