FDAWarningcolor_406x250Three warning letters recently posted by the Food and Drug Administration 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 receive FDA warning letters are given 15 days to respond in writing. Failure to make necessary changes can result in a variety of enforcement actions, including closure of domestic facilities and detention of foreign foods at the U.S. border.

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.

In addition to dirt and old food residue on equipment, “our investigators observed uncovered tofu products on shelves were stored immediately adjacent to a path of condensate dripping from the cooler fan unit located in the walk in cooler used to store tofu,” according to the FDA warning letter.

The inspectors also observed more than 30 flies in the tofu making room, landing on walls and equipment. The October 2016 inspection wasn’t the first time the facility was cited for insects.

“Additionally, our investigator observed flying insects coming into contact with tofu processing equipment such as on the interior surface of a soybean soaking barrel containing soybeans soaking in process and on the conveyer belt area. Similar observations of flying pests were made during our previous inspections of your facility,” according to the warning letter.

Poor employee hygiene habits are also noted in the warning letter, with specific examples including an employee touching his face with his bare hands and then continuing to handle tofu wraps without washing his hands.

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.

“Your written procedures for quality control operations must ensure that reserve samples are collected and held, all established specifications are met, master manufacturing records and batch production records are reviewed and approved, the dietary supplement is packaged and labeled as specified in the master manufacturing record, and returned dietary supplements are properly handled.”

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 did not carry any weight with the FDA.

“Although your firm may contract out dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure the dietary supplements it places into commerce — or causes to be placed into commerce — are not adulterated for failure to comply with dietary supplement CGMP requirements,” the warning letter states.

Problems with the Rock Solid product labels are also addressed in the warning letter. Inspectors found the labels did not have accurate serving size information and failed to list all ingredients.

Blue Pacifico S.A.C. Tacna, Peru
In an Aug. 23, 2016, warning letter to company president Byeong Joon Nam, the FDA outlined “serious violations” in the handling, storing and processing of ready-to-eat frozen flying fish roe products.

During an inspection on March 28-29, 2016, FDA personnel found inadequate refrigeration of incoming fresh, raw fish roe and improper temperatures during processing.

“During our inspection, the FDA investigator observed the washing, cleaning, rubbing, sieving and sorting of the roe under unrefrigerated conditions,” according to the warning letter.

“The cumulative time for these unrefrigerated processing steps was approximately 4.5 hours. The internal temperature of the product was 71.4 degrees F.”

The Peru company also had a number of other inadequate provisions in its Hazard Analysis and Critical Control Point plan.

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