The U.S. Food and Drug Administration (FDA) has published nine warning letters it issued to two dairies, a vegetable farm, an orchard, a bakery, a sunflower-seed manufacturing plant, a seafood facility and two dietary supplement manufacturers.
Doughty Valley Holsteins of Millersburg, OH, and North Florida Holsteins of Bell, FL, received warning letters after selling a calf and a dairy cow for slaughter that were considered adulterated because of unacceptable levels of drug residues in their tissues.
When FDA tested parsnips grown by Ed Fields & Sons in Andover, MN, the agency detected the pesticide Linuron at levels exceeding the tolerance established by regulation set by the U.S. Environmental Protection Agency.
Samples of apple cider manufactured at Iowa Orchard in Urbandale, IA, tested positive for patulin, a mycotoxin that is produced by certain species of Penicillium, Aspergillus and Byssochlamys molds that may grow on a variety of foods, including apples. Exposure over time to high levels of patulin may pose a health hazard.
The mean level of patulin in the two samples was 62.5 and 55.7 parts per billion (ppb), while FDA’s action level is 50 ppb.
FDA found “serious violations” of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food at Serpe & Sons of Wilmington, DE.
Among other things, the facility was cited for cobwebs directly above manufacturing equipment, open bags of flour left near “visible filth,” insufficient storage space, packing sandwich rolls for delivery into large cardboard trays that were stacked directly on the concrete floor of the production area, failure to properly identify and store toxic cleaning compounds, no soap in the hand soap dispenser, and no trash receptacle at the only hand-washing station in the bread production area.
ConAgra Foods’ sunflower-seed manufacturing plant in Afton, MO, was cited for preparing, packing or holding foods under insanitary conditions “whereby they may have become contaminated with filth, or may have been rendered injurious to health.”
The facility’s violations of CGMPs included failure to demonstrate that the procedure used for cleaning and sanitizing equipment is effective, to take reasonable precautions to ensure that production procedures do not contribute to contamination from any source, and to maintain gloves as intact, clean and sanitary for use in food handling.
Seven years ago, Peter Pan and Great Value peanut butters produced by ConAgra were recalled because they were associated with a multi-state Salmonella outbreak.
FDA sent another letter to Pesquera Alvarez y Alvarez of Magallanes, Chile, declaring the company’s frozen, vacuum-packed cooked king crabmeat products “adulterated” after the seafood facility failed to provide an adequate Hazard Analysis and Critical Control Points (HACCP) plan.
The agency also sent letters to two manufacturers of dietary supplements – Aloe Man International Corp of Miami, FL, for CGMP violations and misbranding, and Driven Sports of Franklin Square, NY, for using a new dietary ingredient in products that has been deemed adulterated.
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.
