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FDA Warning Letters: April 17, 2012 Update

From the U.S. Food and Drug Administration warning letters posted since our April 10, 2012 udpate:

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- Société Fromagere de Bouvron of Bouvron, France, which imports cheese to the U.S., was warned that a December 2011 inspection of the company’s processing facility revealed, among other things, that pressure plates with foam rubber-type pads used to compress cheese curds could not be adequately cleaned to guard against Listeria.

Panaderia El Angel of Arlington, WA, warned that a November/December 2011 inspection of the company’s Hispanic bakery revealed, among other things, that the firm was not sequencing production to prevent allergen-containing products from cross-contaminating non-allergen-containing products; now labeling foods — a container of sliced nuts that an employed identified as almonds but the baker identified as walnuts; and not thoroughly cleaning utensils and equipment. The inspection also pointed out places within the facility in need of repair as well as allergen labeling issues.

- K-Brand Farms of Woodridge, NY warned that a November/December 2011 inspection of the company’s shell egg production facility found, among other things, that its Salmonella Enteritidis (SE) prevention plan was inadequate, lacking documentation that tools were being disinfected, pest traps were being maintained or that employees were not maintaining birds at home. 

- Theta Brothers Sports Nutrition, Inc., of Lakewood, NJ, doing business as Protein Factory, warned that an October/November 2011 inspection of the company’s dietary supplement manufacturing facility revealed, among other things, a failure to adequately clean equipment between production of batches of dietary supplements, including products containing allergens such as milk and egg whites, and a lack of documentation that finished products met specifications for identity, purity, strength and composition.

- Concept Asia Food Service, LLC of Seattle, WA warned that a January 2012 inspection of the company’s seafood processing facility revealed, among other things, an inadequate Hazard Analysis and Critical Control Point (HACCP) plan for cooling cooked rice intended for sushi to prevent pathogenic bacteria growth or for storage of tuna rolls to prevent histamine formation.

- River Ranch Fresh Foods, LLC of Salinas, CA warned that environmental and finished product sampling during an October 2011 inspection of the company’s fresh produce processing facility yielded Listeria monocytogenes from the floors of the barrel wash room and the raw material cooler storage room.

The inspection was conducted after a sample of the firm’s “The Farmer’s Market” brand shredded lettuce, produced at the Salinas facility in late September,  was collected and analyzed by the State of Ohio, Department of Agriculture under the United States Department of Agriculture (USDA) Microbial Data Program (MDP)  and yielded Listeria monocytogenes. 

- Custom Seafood Services Inc. of Seattle, WA warned that a February 2012 inspection inspection of the company’s manufacturing facility found, among other things, condensation continuously dripping from overhead pipes, electrical lines, metal vents and support beams onto finished, in-process King crab legs and Dungeness crab; open processing equipment and open containers of water and ice used in processing King crab legs and Dungeness crab; dust accumulation, insect webbing, splattered crab waste, corrosion and peeling paint on the overhead pipes and lines.

- Chung’s and Son Company of Temple Hills, MD warned that a December 2011 inspection of the company’s seafood processing facility revealed, among other things, that it did not have a HACCP plan for ready-to-eat shrimp egg rolls to control the food safety hazards of pathogen growth and potential toxin formation; pathogen survival through cooking; undeclared allergens or food intolerance substances; and metal inclusion.

© Food Safety News
  • Ben Mark

    I noticed there is a new paragraph in the Warning letters: Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.