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.
Market of Choice LLC
Eugene, OR
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
- (redacted)
(redacted)(redacted)(redacted)(redacted)(redacted)(redacted)(redacted)(redacted)
To date, the FDA has not received any updates documenting their progress.
Lastly, they did not submit a revised hazard analysis showing that the hazard of contamination with environmental pathogens requires a preventive control for their RTE products exposed to the environment prior to packaging. The firm’s Feb. 1 written response did not address this hazard in their facility.
(To sign up for a free subscription to Food Safety News, click here.)