July 16, 2019

FDA Warning Letters for Week of March 14, 2012

These are the FDA Warning Letters to food establishments, producers, and farms for the week of March 14, 2012. The most notable letters include a tofu plant with “black build-up” on its equipment (6), and a facility with rodent pellets, rodent traps that held decaying rodents, and rodent gnawed food (7).

1. Creekside Springs, LLC in Salineville, Ohio. This facility processes bottled water. The products processed at this facility are adulterated because they are prepared, packed, or held under unsanitary conditions. They may be contaminated with filth and may be harmful. Water-contact surfaces were not kept clean, and current certificates and notifications of approval were not on file. The source and supply of the water did not have government approval. The ozone levels in the finished products did not comply with law. The company has responded to these violations, but not to the satisfaction of the FDA.

2. Fieser Dairy, Inc. in De Leon Springs, Florida. This farm offered for sale animals for slaughter as food that were adulterated. The animals contained “a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. ยง 360b. Two dairy cows offered for slaughter as food had sulfamethazine. That drug does not have a tolerance level in edible tissues of lactating dairy cattle. The dairy also held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. And the dairy used new animal drugs in an extra-label use that is not approved by federal regulations.

3. Dorsey Farms, Inc. in Caldwell, Idaho This dairy offered for sale an animal for slaughter as food that was adulterated because it contained penicillin higher than the tolerance for residues of penicillin. The dairy also held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. Penicillin was applied in extra-label use; the dose and route of administration were not approved. In addition, the dairy provided a signed certificate stating they were not delivering livestock with an illegal level of drug residues, which was false.

4. Griebel Dairy Farms in Lucinda, Pennsylvania. This dairy also offered for sale an animal for slaughter as food that was adulterated because it had flunixin in the liver tissue. There is no tolerance established for this drug in the edible tissues of veal calves. The dairy also held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. That drug was also used in an extralabel manner.

5. Modern Products, Inc. in Mequon, Wisconsin. This firm is an own-label dietary supplement distributor. They failed to comply with current Good Manufacturing Practice regulations for supplements. All Natural Swiss Formula Broth and Garlic Magic! Spike Gourmet Natural Seasoning was misbranded. The label lists certain terms, namely the words “contains … protein”, but the product does not contain at least 10% of the Dairy Value for protein. The label also states “RICH MINERAL CONTENT”, but the product does not contain at least 20% of the RDI for calcium and iron. It also claims “high potency B-Complex”, but the nutrition label doesn’t list any B vitamins. The serving size for the product was also not included on the label.

6. Fong Kee Tofu Company, Inc. in San Francicso, California. This facility was cited for producing foods that were prepared, packed, or held under unsanitary conditions so they may become contaminated with filth or rendered injurious to health. Pests were not excluded from the processing area. Pigeons were found inside the manufacturing plant. And inspectors observed at least 20 live flies and gnats flying in the manufacturing area. The floor in the production area had built-up food debris, along with thick black residue built-up in the walk-in cooler. Inspectors found that employees drove forklifts, then handled ready-to-eat tofu with the same gloves without washing their hands. One employee touched the tofu with bare hands and packed it. The hand-washing sink drains directly onto the floor. Plastic cooler drapes with black and green build-up scraped directly on top of the uncovered tofu while it was rolled back and forth from the cooling area. In addition, the product was mislabeled because it did not declare all of the food allergens in the product. Some products were completely unlabeled, and others did not have nutrition labels. This facility was not registered with the FDA.

7. Staples, Inc. in Framingham, Massachusetts. This facility in Stockton had serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods. The foods were prepared, packed, or held under unsanitary conditions. Rodent pellets were directly on, or in close vicinity to, packages of at least 11 different food products. Twenty-three out of 39 rodent traps held dead and decaying rodents. Rodent-gnawed holes were found on individual packages of at least 10 different food products, including candies, crackers, creamers, pistachios, ramen noodles, and bottled water. Doors to the exterior had gaps large enough for rodents to enter. Lab analysis confirmed rodent gnawed peanut butter and cheese sandwich crackers. The firm responded to these problems and destroyed food products. But they didn’t provide documentation of corrections, such as photographs or pest control records.

8. Sebastian Joe’s Ice Cream Commissary in Minneapolis, MN. This facility misbranded Caramel Cashew ice cream product by not identifying milk, soybean, and egg on the label. In addition, the ingredient label did not include all of the ingredients used to make the product. Some of the ingredients contained multiple ingredients themselves. The firm responded to the original letter, but needs to be re-inspected and some of the corrections were not complete.

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