fdaREDwarning_406x250Bao International Inc. in La Canada, CA, Mama Turney’s Homemade Pies Inc. and  Southern Aire Seafood Inc., both in Nashville, and MBDR Foods LLC in Lenexa, KS all have one thing in common.

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:

  • On 10/13/2016, a live fly was observed resting on the pie shells and on the pie filling of finished baked 3-inch pecan pies, which were staged on a sheet pan for cooling in the Cooling Area.
  • On 10/11/2016, a live fly was observed resting on a pie rack containing baked 9-inch chocolate pies, which were staged for cooling in the Cooling Area.
  • On 10/11/2016, two live flies were observed inside a cardboard packaging box used to package a case of baked 9-inch chess pies in the Wrapping/Packing Area.
  • On 10/11/2016, a live fly was observed on the container lids used to package baked 9-inch pies in the Wrapping/Packing Area.
  • On 10/11/2016, a live fly was observed on a portable fan used in the Wrapping/Packing Area; the fan was approximately 3 to 4 inches from baked 9-inch chocolate pies.
  • On 10/13/2016, a live fly was observed resting on the 3-inch pie wrapping machine in the Wrapping/Packing Area; the wrapping machine was used to package baked 3-inch pies.
  • On 10/12/2016, an apparent stinkbug insect was observed crawling down a storage rack containing baked 9-inch lemon chess pies that had been packaged in the Wrapping/Packing Area.
  • On 10/11/2016, approximately three apparent rodent excreta pellets were observed underneath the mop sink in the northwest corner of the production area during the manufacture of 9”-inchchocolate pies.

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:

  • You explain in your written response that your dollies have been labeled and employees that handle trash do not handle cooked crab.
  • You explain in your written response that the PVC pipe has been removed and cleaned. Employees trained to keep PVC pipe cleaned and sanitized.
  • You explain that a tray has been built and installed to prevent water droplets.
  • You explain that you trained employees to change the water and use chlorine test strips to monitor chlorine.
  • You provided excessive training to your employees.
  • You installed a back flow prevention device on the hose.
  • You installed end caps on rakes.
  • You removed and replaced with new labeled containers.

“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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