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FDA warning letters: Pests, debris, seafood HACCP problems

Sunday, November 6, 2016 23:23
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One of the two most recently posted food-related warning letters from the U.S. Food and Drug Administration went to The Smoked Goat Co. Inc. in Havre de Grace, MD.

The warning letter from the agency’s Baltimore District Office, dated Oct. 24, told the company that an inspection of its facility from Aug. 12-17 found “significant violations” of Current Good Manufacturing Practices regulations.

These violations consisted of failure to store foods under conditions and controls necessary to minimize contamination, the warning letter stated.

“During the current inspection, your firm was observed with damaged bags of products too numerous to count, identified as waste products that were commingled with human food products available for distribution,” FDA wrote.

Other problems included a failure to provide adequate screening or other protection against pests, according to the warning letter.

“During the current inspection, your firm’s second food storage container was observed with apparent rodent excreta pellets too numerous to count located near woven, permeable packages of grain. Additionally, insects too numerous to count were observed around your packaged human food products in storage,” the agency stated.

Further, the plant is not constructed so that it can be adequately cleaned, kept clean and kept in good repair, the letter pointed out. Storage containers of human food products were surrounded by uncut grass, expired animal feed and piles of debris.

“Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure or injunction,” FDA stated.

The second recently posted food-related FDA warning letter, dated July 25, was addressed to Pacific Export Corporation in Remedios, Chiriqui, Panama.

The agency wrote that “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations were observed during a March 3-4 inspection of the company’s seafood processing facility.

Among several cited issues, FDA noted that the failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with federal regulations results in the fish or fishery products being considered adulterated.

“Accordingly, your scombroid species fish are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health,” according to the warning letter.

The company responded March 22 to FDA’s Inspectional Observations with a timeline of estimated dates when corrections would be implemented. However, the response did not include any documentation to substantiate implementation of these corrections nor a copy of its corrected HACCP plan, FDA stated.

The agency told the firm that it must have a HACCP plan listing the critical control points to prevent, eliminate or reduce to acceptable levels food safety hazards associated with its products.

For example, the warning letter noted, “… your firm’s HACCP plan for Mahi Mahi/Tuna Headed and Gutted Fresh does not list the critical control points of raw material and in-process iced storage and unrefrigerated processing for controlling the food safety hazard of scombrotoxin formation.”

FDA recommended that the fish be completely and continuously surrounded by ice throughout the storage time and not be exposed to ambient temperatures above 40 degrees F for more than a certain number of hours, among other specific suggestions.

Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.

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