It is FDA's practice to issue Warning Letters in order to provide individuals and companies an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. The agency's position is that it issues Warning Letters only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected.
A Warning Letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act ("the Act"). Below is a brief synopsis of recent food-related Warning Letters.
- On July 22, 2013, the FDA issued a Warning Letter to Mark Palmer, President of Ocean Beauty Seafoods, LLC, a manufacturing facility located in Seattle, Washington. During an inspection, the agency observed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123), and the Current Good Manufacturing Practice (CGMP) regulation for foods. (21 CFR 123 & 110). Because the facility failed to have a HACCP plan in place, its fish and fishery products were rendered adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC. § 342(a)(4). The agency also took samples that tested positive for Listeria monocytogenes. Accordingly, the company's hot and cold smoked salmon products were deemed adulterated, in that they were prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
- On July 15, 2013, the FDA issued a Warning Letter to Steve Ellenberger, Owner and CEO of The Bagel Works Café, Inc., a manufacturing facility located in Kansas City, Kansas. During an inspection, the agency observed serious violations of the CGMP regulations in Part 110 (21 CFR 110). These violations caused the foods manufactured at the facility to be adulterated within the meaning of section 402(a)(4) of the Act [21 USC §342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. The company had a prior inspection in May 2013 and the July inspection revealed the same or similar conditions as the earlier inspection. The facility failed to take effective measures to exclude pests from processing areas, to protect food from contamination, to maintain equipment and finished food in an acceptable condition, and to maintain the physical facilities in a sanitary condition.
- On July 12, 2013, the FDA issued a Warning Letter to Roy S Tucillo, Sr, President of Advanced Foods, Inc., a seafood establishment located in Westbury, New York. During an inspection, the agency observed serious violations of the seafood HACCP regulation, violating the specific requirements for imported fish and fishery products, as set forth in 21 CFR 123.12. The establishment needed to implement written verification procedures that included product specifications and an affirmative step(s) for ensuring that the fish and fishery products that it imports into the United States were processed in accordance with the seafood HACCP regulation. However, the agency found that the establishment had no written verification procedures and did not implement an affirmative step for fishery products that it imported.
- On July 11, 2013, the FDA issued a Warning Letter to Michelle L. Myrter, President & Co-Owner of Castle Cheese, Inc., a food facility located in Slippery Rock, PA. During an inspection, agency investigators obtained product labeling and manufacturing records for several cheese products and found violations of the food labeling regulations, 21 CFR Part 101, that caused the company's International Packing Parmesan Cheese, Romano 100% Grated Cheese, and 100% Grated Parmesan Cheese products to be misbranded within the meaning of section 403 of the Act [21 USC § 343]. Specifically, the company omitted valuable constituent, substituted varieties of cheeses for those declared on the products' labels, failed to use the common name of each ingredient, and contained ingredients not permitted by the standards prescribed by regulation. Additionally, these products were deemed to be adulterated within the meaning of sections 402(b)(1), 402(b)(2), and 402(b)(4) of the Act [21 USC § 342(b)(1), 342(b)(2) and 342(b)(4)].
The companies had fifteen days to respond to the agency in writing to explain the steps taken to correct the violations. FDA will evaluate the responses and can take regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures.
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