FDA Warning Letters Go To Tofu Production Plant & Nutritional Supplement Maker
January 09, 2017
(NATIONAL) -- Three warning letters recently posted by the Food and Drug Administration (FDA) cited food safety violations at a tofu production plant in California, a supplement company in Nebraska and a supplier of fish roe based in Peru.
Companies that received the government warning letters have 15 days to respond in writing.
Failure to make the necessary changes can result in a variety of enforcement actions, including closure of domestic facilities
Tofu Yu LLC, Berkely, CA
In a Dec. 22, 2016, warning letter to co-owner and president Kevin E. Strong, the FDA cited “significant violations” ranging from dirty equipment to problems with product labeling found during inspections on Oct. 11 and 25, 2016.
The Berkeley facility’s ready-to-eat tofu and tofu products, including tofu veggie wraps, are therefore considered adulterated under federal law, according to Food Safety News. Among other things, "poor employee hygiene habits" were noted in the warning letter, with specific examples.
Rock Solid Nutrition LLC, Omaha, NE
In a Dec, 22, 2016, warning letter to co-owners Sean H. Loseke and Heath M. Murray, the FDA cited Rock Solid Nutrition for “serious violations of the Federal Food, Drug and Cosmetic Act.”
“Specifically, you have not established written procedures for quality control operations for ensuring the quality of incoming finished dietary supplement products, such as "Pre-Pump", "Whey Isolate", and "Strength Test,” according to the warning letter.
The FDA inspected the supplement company’s operation in Omaha from July 8-12, 2016. Inspectors noted the company was failing to follow the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements as detailed by federal law. The company’s response that the supplements are made by a contractor were not met with agreement by the FDA.
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