nd Drug Administration has published nine warning letters it issued to food manufacturers and processors between March 6 and 24, 2014.Woodcrest Dairy of Lisbon, NY, the home farm of William Bremer in Independence, WI, and Monica Farms of North Bangor, NY, received warning letters after selling cows and a calf for slaughter that FDA officials considered adulterated because of unacceptable levels of drug residues in their tissues.
Two seafood-processing facilities received warning letters from FDA for “serious violations” of Hazard Analysis and Critical Control Point (HACCP) regulations.
Citations concerning Marfish’s Miami, FL, facility included condensation on the walls, ceiling, and floor in the cooler and freezer; no hot water in the processing room three-compartment sink and in the hand-washing sink, and no sanitation control records to document key points of sanitation.
“Although you promised a written response at the close of the inspection [on December 17 and 18, 2013] to address the form FDA 483, Inspectional Observations, we have not yet received your written response,” the agency wrote.
Gulf Shrimp Co. of Plantsville, CT, was cited by FDA for a HACCP plan that lacked certain monitoring procedures and record-keeping steps. FDA also took issue with the company’s corrective action plans for histamine-producing species, such as fresh tuna, and all fresh pasteurized crab meat, fresh smoked products, and ready-to-eat soup.
Seafood importer Best Choice Trading Corp. of Brooklyn, NY, also received a warning letter regarding HACCP violations.
The company’s main cited violation was a failure to implement an affirmative step for its frozen vacuum-packed raw ground tuna meat fish to ensure that the product was processed in accordance with the seafood HACCP regulations. On Oct. 28, 2013, FDA officials collected a sample of tuna offered for import and stated that they found decomposition in it.
Jonathan Allgyer received a letter for violations of the prevention of Salmonella Enteritidis (SE) at his shell egg production facility in Shullsburg, WI. According to the letter, Allgyer failed to perform environmental testing for SE and to fully implement the “Biosecurity Measures,” “Pest Control” and “Biosecurity Plan” section of his written SE-prevention plan.
FDA found “significant deviations” from regulations for Current Good Manufacturing Practice (CGMP) in the manufacturing, packing, or holding of human food at Branson Baking Co. in Branson, MO. Violations included failure to appropriately clean and sanitize equipment, to designate an individual or individuals to supervise overall sanitation in the plant, to take appropriate precautions to prevent contamination, and failure by employees to adequately wash their hands prior to starting work manufacturing food.
In addition, the letter noted that the facility is not constructed in a manner to allow the floors to be adequately cleaned and kept clean, that food contact surfaces used for the manufacturing of apple fritters (bear claws) and other yeast dough products have wide cracks which allow for the accumulation of food particles and other foreign matter, and that the firm has not registered with FDA as a food facility.
Finally, FDA stated that Libi Labs of Largo, FL, violated CGMP regulations for dietary supplements. Of the number of violations listed, FDA’s letter stated that the company did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use, did not establish component specifications for each component in the dietary supplement products, and did not prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that they manufacture to ensure uniformity in the finished batch from batch to batch.
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.
