They’ve recently received warning letters from the U.S. Food and Drug Association. Warning letters usually follow FDA inspections that turned up food safety issues that remain unresolved. Warning letters typically mean the clock has started, giving recipients 15 working days to respond to FDA.
Bao International Inc. is a seafood establishment with “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, according to the Jan. 30 warning letter.
In the warning letter, FDA said Bao’s fish and fish products were adulterated, specifically its frozen breaded squid rings and tentacles.
“You did not comply with 21 CFR 123.12(a)(2) in that you do not have or have not implemented written verification procedures, product specifications, and an affirmative step for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation.,” according to the letter. “Specifically, you failed to provide adequate product specifications and an affirmative step for the following products …”
Mama Turney’s, a bakery in Whites Creek, TN, was warned in a January letter about “serious violations” of FDA’s Current Good Manufacturing Practices. FDA inspectors observed the following issues in the production areas of the bakery during the inspection:
FDA said similar conditions were found during inspections of the bakery in 2009 and 2010.
Southern Air’s seafood processing facility in Irvington, AL, was found during inspection to have serious violations of both the seafood HACCP rule and Current Good Manufacturing Practices. The seafood company did respond in part to FDA’s concerns as expressed in the Form 483 report of inspection observations. But it apparently fell short. The Feb. 8 warning letter explained it this way:
“You provided the following corrective actions to the deviations noted above:
“Although your proposed corrective actions begin to address the Agency’s concerns, you failed to provide any evidence supporting your actions. Your corrective action will be confirmed during an inspection at a later date,” according to the FDA warning.
FDA’s warning letter to MBDR Foods went out to the manufacturer of acidified food products on Feb. 3.
“As a commercial processor in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2), “the FDA warning letter says
“However, our inspection revealed you failed to file a scheduled process with FDA for your firm’s Hopsing Stir Fry Sauce, Hopsing Sweet and Sour Sauce, and Hopsing General Tso’s Sauce.”
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