The latest group of warning letters posted by the U.S. Food and Drug Administration (FDA) includes one sent to a food warehouse and repacking facility in Fremont, CA, regarding pest activity. In a July 13, 2015, warning letter to Bharat Bazaar Inc. of Union City, CA, FDA stated that inspectors visiting the Fremont facility this past April found apparent rodent gnaw holes and rodent excreta pellets in areas where flour, moong (mung) beans and cumin seeds were being stored and repacked.

FDA WarningFurther, the agency told the company that the vacuum cleaner used to clean the flour repacking machine was observed being used to clean apparent rodent excreta pellets from the floor and wood shelves of the facility. FDA told the firm to properly store equipment, remove litter, and remove waste within the immediate vicinity of the plant buildings or structures which may attract, harbor, or provide a breeding place for pests. Clements Foods Company of Oklahoma City, OK, was warned by FDA in a June 26, 2015, letter that an inspection of the company’s plant where a variety of acidified foods are manufactured revealed “serious violations” of federal regulations for acidified foods. Specifically, the company failed to provide FDA with information about the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size. FDA acknowledged the firm’s response in February, but the agency noted that no details or timeframe for completion were provided. Clements Foods also failed to construct or maintain the plant to prevent drip and condensate from contaminating food and food contact surfaces, FDA stated. “Specifically, our investigator observed water condensate drops at the bottoms of the overhead piping in the Dressing Production Room. Water droplets could drop onto the conveyor rack that carries the food containers (lids),” the warning letter stated. FDA deemed inadequate the company’s response to this concern. In a July 16, 2015, warning letter, FDA told LaCausa Inc. (dba, Kim Nguan Trading) in South El Monte, CA, that a May 4 inspection of the fish and fishery products importer found violations of seafood HACCP regulations. The FDA inspection found problems with processing regulations relating to the prepared Anchovy, prepared Soft Herring and prepared Cuttlefish products, the agency’s letter stated. Without correction of the problems, FDA stated that the products could be refused admission to the U.S., seized, and/or placed on “detention without physical examination.” Illegal drug residues in the tissues of animals slaughtered for food were the subject of two other warning letters FDA recently posted. Vander Hoff Bros. Dairy LLC of Reading, MI, was told in a letter dated June 30, 2015, that a dairy cow sold on or about June 26, 2014, had higher-than-allowable levels of desfuroylceftiofur (marker residue for ceftiofur) in both muscle and kidney tissues. In addition, FDA’s letter stated that the dairy adulterated the new animal drug VetaMeg (flunixin meglumine, ANADA 200-308) by not using it as directed by the approved labeling, and that Stephen Vander Hoff had provided a Livestock Owner Certificate on or about Jan. 1, 2014, indicating that a dairy cow was not adulterated although it contained “violative residues” of desfuroylceftiofur and flunixin. FDA wrote to Jason L. Riley of Argyle, WI, on July 21, 2015, to state that an agency investigation had revealed that he sold a heifer for slaughter as food on or about Feb. 25, 2015, and that analysis of tissue samples later found the presence of sulfamethazine at 1.54 parts per million (ppm) in the liver tissue of this animal. However, the agency’s tolerance is 0.1 ppm for residues of sulfamethazine in the uncooked edible tissue of cattle. The agency’s warning letter also stated that Riley failed to maintain treatment records for animals that he medicates and did not keep records of the purchase and sale of animals offered for slaughter for human food. In each letter, FDA requested that the companies provide written responses detailing steps taken to bring their facilities into compliance with food-safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.

Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law. (To sign up for a free subscription to Food Safety News, click here.)