Recently posted warning letters from the U.S. Food and Drug Administration (FDA) went to an Asian food processor and distributor based in Brooklyn, NY, and to two dairy operations, one in Idaho and one in Maryland. On Dec. 9, FDA’s Philadelphia district office sent a letter to New Yung Wah Trading Company in Brooklyn notifying the owners that agency inspectors had allegedly found “significant violations” of Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food at the company’s warehouse in McKees Rocks, PA. In particular, FDA stated that inspectors had noted an apparently active rodent nest in a box of thawing meat, rodent carcasses along three walls of the facility, gnaw holes and rodent excreta in food cartons, and that “birds were observed flying through the facility and landing and defecating on stored food products.” In addition, the letter stated that the firm failed: to use rodenticides to prevent contamination of food, food-contact surfaces and food packaging; to have properly installed and maintained plumbing to provide adequate floor drainage in the warehouse; to close up pest-access areas, and to remove litter and waste that may attract pests, among other allegations. FDA further stated that the company’s written response that it had “aggressively addressed the deviations” was not considered acceptable because no documentation of correction actions was provided for the agency’s review. Gerratt Dairy in Hazelton, ID, was sent a warning letter on Dec. 15 from the agency’s Bothell, WA, district office noting that an investigation in September 2014 had found several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, FDA alleged that dairy owner Dale Gerratt had offered for sale a dairy cow whose kidney tissue contained ampicillin levels higher than the legal limit. In addition, the agency stated that new animal drugs Polyflex, Di-Methox, Tetroxy-LA and Excede had not been administered as directed by their approved labels or by the servicing veterinarian’s prescription. Therefore, “use of these drugs in this manner is an extralabel use,” the FDA warning letter stated. Also, some of these drugs are not for use in lactating dairy animals, the letter noted. FDA’s Baltimore district office sent a warning letter on Nov. 24 to My Lady’s Manor Farm Inc. of Monkton, MD,  to notify owner Robert S. Smith that an investigation of his operation on Oct. 14 and 16, 2014, revealed violations of the FD&C Act. The agency stated that a culled dairy cow had been sold in June for slaughter as food whose kidney tissue contained higher-than-acceptable levels of neomycin residue. “Our investigation also found that you hold animals under conditions that are inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4),” the letter reads. FDA further stated that the new animal drug Neosol Oral had not been used as directed by its approved labeling, without following the recommended dose, not under the supervision of a licensed veterinarian, and that the drug is not to be used in female dairy cattle 20 months of age or older. FDA noted that such use renders the drug unsafe and adulterated. In each warning letter, FDA requested that the companies provide written responses detailing steps taken to bring the 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.

  • Lars Krusell

    Strange actions! 15 more days of violating existing regulation. The rat infestation is a direct threat to human health and operations should have been stopped immediately and affected distributed procucts recalled.

  • Hollie Sinkora

    Lars, You are so on the money. Of course they should have shut down right away. You and I know how easily the FDA can be bought.