The U.S. Food and Drug Administration (FDA) took seven firms to task in recently posted warning letters. Recipients included a ready-to-eat food manufacturing facility in Michigan, a dietary supplement and seafood processor in Chicago, businesses involved in juice marketing and manufacturing in Hawaii and California, and two dairy farms in Michigan. Saranac Brand Foods Inc. in Saranac, MI, was sent a letter Aug. 12 from FDA’s Detroit District Office stating that an inspection done Feb. 1-9 of the firm’s ready-to-eat cold salad, sauce, and dip plant found Listeria monocytogenes in the pasta and deli salad production room. FDA noted that an inspection in June 2014 by the Michigan Department of Agricultural and Rural Development had also identified the presence of Listeria monocytogenes in the facility. “The environmental sampling results highlight the need to better control L. monocytogenes in your firm’s environment. We recommend that you reassess your firm’s cleaning and sanitation operation,” the warning letter stated. The letter also pointed out observed violations of Current Good Manufacturing Practice (CGMP) regulations such as a rusting ceiling and dripping condensate, inadequate ventilation, and an employee using a hose to spray a floor in a processing area near where bulk food ingredients were being stored. “The water from the floor aerosolized on impact and sent water particles and debris from the floor into the air. All the food containers were covered in water and visible adhering debris,” FDA stated. While the firm’s written response was acknowledged, the agency pointed out that employee retraining was not addressed nor was whether the raw materials were evaluated and removed from the processing area or used in production. FDA sent a warning letter dated March 15 of this year to Global Marketing Enterprises regarding problems observed during a May 21 through July 8, 2015, inspection of the company’s dietary supplement and seafood processing facility at 1801 S. Canal St. in Chicago. These included “serious violations” of CGMP regulations for dietary supplements (Garcinia cambogia) and also failure to have and implement a HACCP plan for seafood (frozen raw squid, farm-raised head-on shrimp, and round scad products). As a result, there is no plan to control the food safety hazards of Clostridium botulinum growth and toxin formation and/or undeclared sulfiting agents, according to FDA. The agency’s warning letter also mentioned product labeling issues for the company’s “Caffeine Powder” and stated that, based on a review of the “therapeutic claims made in the labeling for this product,” the agency had “… determined that this product is promoted for conditions that cause the product to be a drug … .” On Aug. 26, FDA sent warning letters to Healing Noni LLC and KCE LLC, both at the same address on Kamaili Road in Pahoa, HI. Healing Noni was told that an inspection of the facility from Dec. 17-22, 2015, and a review of the firm’s website revealed that orders were being taken for noni juice and goji juice products and that claims for these products establish that they are “unapproved new drugs” because “they are intended for use in the cure, mitigation, treatment, or prevention of disease.” The agency’s letter listed a number of labeling claims that it stated provided evidence that the juice products are intended for use as drugs. Correction action included in a written response from the company submitted on Jan. 8 would be reviewed at a future inspection, FDA stated. FDA’s warning letter to KCE LLC noted similar issues but also mentioned CGMP violations observed during the Dec. 17-22, 2015, inspection. These included not preparing and following a written master manufacturing record (MMR) for each unique formulation of dietary supplement made, and for each batch size, to insure uniformity in the finished batches. Additional problems with the grounds of the facility were cited, including improperly stored equipment, overgrown weeds, and litter and waste, according to FDA. Ratzlaff Ranch in Sebastopol, CA, was sent a warning letter from FDA on Aug. 26 to state that “serious violations” of the juice HACCP regulations were observed there during a March 14 and 16 inspection. Although federal law requires a written HACCP plan to control any food safety hazards “reasonably likely to occur,” FDA stated that “your firm does not have a HACCP plan for your unpasteurized juice product to control the hazards of pathogens and patulin.” Because even a small percentage of moldy apples may contain high enough levels of patulin to be injurious, the letter stated, receiving and culling steps should be monitored and records should be kept.
On Aug. 4, FDA wrote to Noll Dairy Farm in Croswell, MI, about the inspection done there from Feb. 17 through March 3. The agency’s investigation revealed that on or about Sept. 21, 2015, the farm sold a dairy cow for slaughter as food which was later found to have desfuroylceftiofur, a marker residue for ceftiofur, at 3.4 parts per million (ppm) in the kidney tissue and flunixin at .144 ppm in the liver. However, FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle and a tolerance of 0.125 ppm for residues of flunixin in the liver. The agency also noted a failure to maintain complete treatment records to make sure that medicated animals are withheld from slaughter “for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.” The dairy provided a signed certification on or about Sept. 14, 2014, that livestock being sold did not have illegal levels of drug residues, FDA wrote. However, a culled dairy cow was later sold containing “violative residues of desfuroylceftiofur and flunixin,” which amounts to providing a “false guaranty,” according to the agency. RDJ Dairy Farm of Rose City, MI, was sent a warning letter from FDA on Aug. 2 regarding the agency’s inspection done on May 17 and June 8. Investigators found that an animal sold for slaughter as food on or about Sept. 1, 2015, had desfuroylceftiofur at 1.62 ppm in the kidney tissue, while the FDA tolerance is 0.4 ppm. The dairy farm also failed to maintain complete treatments records, expired animal drugs were found on-site, and a “false guaranty” was provided that livestock being sold do not have illegal levels of drug residues, FDA wrote. The agency acknowledged a response from the farm owner of a newly implemented “Drug Treatment Log,” but noted that the treatment record was incomplete and missing data. Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring. (To sign up for a free subscription to Food Safety News, click here.)