The U.S. Food and Drug Administration published eight warning letters last week that were issued to food manufacturers and processors mainly in February.
Reyskens Dairy in Custer, OH, and Ed Vander Woude Dairy in San Jacinto, CA, received warning letters after selling cows for slaughter that were considered adulterated because of unacceptable levels of drug residues in their tissues.
Alex Jackson and Wayne Jackson of Union, ME, received a letter about not administering six drugs to their animals as directed by their approved labeling or by a servicing veterinarian’s prescription, resulting in unacceptable levels of flunixin in the kidney tissue of a bob veal calf sold for slaughter.
An investigation of animal dealer Wilton Black’s operation in Litchfield, ME, found that a calf he had purchased, hauled and sold for slaughter had unacceptable levels of drug residues in its tissues.
“If you do not want to hold the medicated animal, then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal,” stated FDA’s letter.
Bluegrass Dairy and Food’s whey powder manufacturing facility in Glasgow, KY, was cited for environmental sampling which identified the presence of Salmonella.
“This was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for Salmonella,” read the warning letter.
Schafer Fisheries in Fulton, IL, and Pulmuone Foods USA in Gilroy, CA, had serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations in their processing facilities.
FDA found that Schafer’s fish franks, fish salami and gefilte fish were adulterated “in that they have been prepared, packed, or held under unsanitary conditions whereby they may have been rendered injurious to health.”
Pulmuone responded to issues inspectors raised in September 2013, but in the February warning letter, FDA stated that “your response is not adequate in that revised HACCP plans were not presented. To determine the adequacy of your response, we will need to review your written HACCP plans.”
Finally, FDA found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements at a Maximus Niterider International Group packaging and distribution facility in Santa Fe Springs, CA.
According to the warning letter, the company failed to follow written quality control procedures and to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement manufactured. Their batch production records for packaging and labeling products also failed to include complete information relating to the production and control of each batch, and certain product labels failed to meet branding requirements.
In each letter, FDA requested that the farms and companies provide written responses detailing steps taken to bring the firms into compliance with food safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.
