July 15, 2024

FDA Warning Letter to Frito-Lay’s Tennessee Facility

The FDA has sent a warning letter to Frito-Lay’s Tennessee facility, sating that inspections in May and June 2015 “revealed serious violations of FDA’s Current Good Manufacturing Practice requirements.” That means food products held at that facility are considered adulterated because they were “prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.”

FDAFrito-Lay has responded to Form FDA 483, and included a number of corrective actions. The adequacy of those actions will be assessed during the next inspection.

The inspections in May and June revealed that the roof was leaky, often directly over exposed product through the facility. The equipment wash and sanitize bay, walls, and floor in the pretzel processing area were worn and soiled. The air duct work in the pretzel processing area was wrapped in plastic sheeting.

In addition, the interior ceiling in production areas throughout the facility had numerous spots with peeling and missing paint. The ceiling directly above the mixing deck where batches of cookies and crackers are mixed had water stains, missing paint, and a water diverter/diaper.

Chocolate chip cookie dough was leaking from a pinch point on the dough hopper. At least three cheese filling machines had areas of adhering product leaking from pump seals. And corrosion and adhering debris was observed on protective fan shrouds above ready-to-eat product.

Inspectors found that inner walls and fixtures throughout most of the production area were soiled with food debris and dust. Many food contact surfaces were soiled with adhering food.

All in all, there were 26 serious violations noted, including employees touching non-food contact surfaces that were soiled, then handling ready-to-eat product during processing and before packaging.

Update: Frito-Lay contacted us  on August 25, 2015 to provide their side of the story.

“Food safety is our highest priority at Frito-Lay and we take this matter very seriously.  We were surprised to receive a warning letter from the FDA regarding a recent inspection of our Pulaski, Tenn. manufacturing facility.  We have been working cooperatively with the agency to respond to a review of the facility conducted in late May with the findings report issued June 1, 2015.  Important to note is that the FDA in no way suggested or requested that we stop production and sale of product made in our Pulaski facility.

While our assessment differs from some of the agency’s characterizations, we have provided background information and explanations to add clarity to their evaluation, and we have worked quickly to address the report’s observations – the vast majority of which were resolved in less than 30 days.

Frito-Lay has a long track record of leadership in food manufacturing and safety and has never received a warning of this kind. We look forward to resolving this matter quickly.”


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