A diverse group of food facilities recently received warning letters from the U.S. Food and Drug Administration (FDA). Among those targeted with the formal warnings are:

  • FDAWarningcolor_406x250The  manufacturer of low-acid canned foods in Montreal.
  • A  seafood processing facility in Hayward, CA.
  • A seafood processing and importer establishment tin Hunts Point, NY.
  • A bakery manufacturing facility in Sioux Center, IA.
  • A juice manufacturing facility in Fresno, CA.
  • An acidified food manufacturer in Wichita, KS.
  • An apple cider processing facility in Berlin Heights, OH.

Here are more of the details. Saputo Dairy Foods USA, LLC, which is associated with Saputo Inc. in Montreal, manufacturers low-acid canned foods at a Frederick, MD, facility. FDA inspected the the manufacturer between Aug. 31 and Sept. 22 in 2015. The inspection found “significant deviations” from the Low Acid Canned Food (LACF) regulations and current Good Manufacturing Practices (cGMPs). FDA found that Saputo products, non-dairy creamer in cups, were being made in deviation of several regulations, including errors in sterilizing machines. The seafood processing facility in Hayward, CA, owned by MGH Gourmet Inc., was found with “serious violations” of seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The FDA warning letter informed MGH that its crab cakes, smoked salmon, lobster, shrimp, salon, smoked trout and ahi tuna canapés products are all considered to be adulterate because without following the seafood HACCP regulations, the fish and fishery products are all deemed to have been prepared, packed or held under insanitary conditions. The California processor was warned its products might be seized by federal officials or the facility enjoined from operating it prompt action is not taken to correct the violations. FDA especially warned the company to conduct a hazard analysis for each of its products. Lupe Gourmet Inc. in Hunts Point, NY, received a very similar warning letter. It was told its ready-to-eat, refrigerated, vacuum-packaged whole mullet roe (Bottarga di Muggine) and its ready to eat refrigerated, anchovy fillets marinated in oil (Filet diclici) are both adulterated because they were made without following seafood HACCPs. The Lupe Gourmet Inc facility was inspected between Dec. 16 and 23, 2015; and the company responded to FDA’s Form 483 inspection observations on Jan. 11. In a March 21 warning letter, FDA said it has heard nothing in the way of followup on the company’s promise to get training and implement a HACCP program. During an inspection this past November, Casey’s Bakery Inc. in Sioux Center, IA, was found to be out of compliance with current Good Manufacturing Practice (cGMP) regulation. In a warning letter, FDA said Casey’s has failed to respond to its inspection observations. It found the bakery is not properly maintaining equipment with proper cleaning and sanitizing. Specifically, dough sheeter used for doughnut and pastry dough, was left with product residue on it when not in use. Further a dry clean sweeper was observed to be effective. FDA said the poor sanitation and equipment maintenance could lead to cross contamination. Uncovered raw hamburger buns were also being stored directly below condensation dripping from the ceiling. FDA also raised a long list of misbranding issues with Casey’s. FDA inspected Pressed Juicery in Fresno, CA, this past October, finding the facility with “serious violations” of the agency’s juice HACCP regulations. The company responded to FDA’s Form 483 inspection observations on Nov. 11, 2015. In a March 23 warning letter, FDA said the company’s response was inadequate. Its juice HACCP plan does not include control measures to result in a 5-log reduction of the “most pertinent microorganisms” of public health significance that like will occur. A “5-log reduction” means lowering the number of microorganisms by 100,000-fold, that is, if a surface has 100,000 pathogenic microbes on it, a 5-log reduction would reduce the number of microorganisms to one. FDA said Pressed Juicery has not taken into consideration the pertinent microorganism C. botulinum for low acid products. In its Nov. 11 response, the company said C. botulinum is unlikely to occur because a “Keep Refrigerated” label is used along with a warning label on the unpasteurized juice. In the warning letter, FDA says it believes the hazards must be addressed. Holmes Made Salsa, an acidified foods manufacturer in Wichita, KS, was inspected by FDA between Jan. 5 and 19. It found the acidified food products made there are adulterated. Such manufacturers are required to adhere to acidified food regulations and may require an emergency permit to continue in business. FDA acknowledged Holmes responded to its inspection, but said not enough information was provided. Burnham Orchards Inc., an apple cider processing facility, in Berlin Heights, OH, was also the target of a FDA warning letter in March. It was also cited for “serious violations” of juice HACCP and current Good Manufacturing Practice regulation for foods. Burnham’s hazard analysis work apparently included no mention of E. coli O157:H7, cryptosporidium parvum, patulin or metals. FDA also found its temperature controls inadequate and took exception to the water safety, pest controls and failure to prevent cross contamination. (To sign up for a free subscription to Food Safety News, click here.)