WASHINGTON – The Food and Drug Administration served Austin, Texas-based Whole Foods Corp. with a warning letter that detailed numerous food safety violations at a company owned food manufacturing facility in Massachusetts.
In the letter, Joseph Matrisciano Jr., district director of the FDA’s New England District Office wrote that a series of inspections conducted between Feb. 10 and Feb. 16 revealed serious violations of the FDA’s Current Good Manufacturing Practice regulations for manufacturing, packing or handling human food.
“These violations cause the food products manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act … in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.”
Among the violations:
- On Feb. 10, inspectors collected 100 swabs/subs from food contact and non-food contact surfaces throughout the facility. The environmental sample tested positive for non-pathogenic Listeria welshimeri, which indicates that conditions exists in and on food processing equipment that would support the presence and growth of Listeria monocytogenes.
- On Feb. 16, uncovered ready-to-eat egg salad was held in large white barrels that were placed in an area below a condenser that an inspector observed to be dripping.
- On the same date, an employee was observed cleaning and touching contact work surfaces, and then packaging and handling exposed product without washing their hands or changing gloves in between tasks.
FDA acknowledged receiving a written response from Whole Foods on March 17, which included steps the company would take to remedy the violations. However, FDA found Whole Foods’ response inadequate.
“We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented,” FDA said. “This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections.”
The agency gave Whole Foods 15 days to send written documentation of specific corrective or preventive actions the company planned to take to correct the violations.
Read the full letter here.
