Silver Spring, MD—The U.S. Food and Drug Administration (FDA) issued a warning letter to Austin, TX-based Whole Foods Market for not sufficiently addressing the long list of food safety violations accrued at the Whole Foods Market North Atlantic Kitchen after a series of inspections this past February. This facility is responsible for the manufacturing and packing of prepared foods for 74 stores in North Atlantic and Northeast regions (Maine, New Hampshire, Massachusetts, Rhode Island, Connecticut, New York, Northern New Jersey).
The letter states that the aforementioned inspections found “serious violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations for manufacturing, packing, or holding human food,” which according to the Federal Food, Drug and Cosmetic Act makes them adulterated, “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 these violations, after collecting 100 swabs from food contact and non-food contact surfaces, FDA laboratory analysis found that one of the swabs from a food contact surface contained non-pathogenic bacteria Listeria welshimeri. This is an indicator for the probable presence of Listeria monocytogenes.
According to the letter, FDA received a written communication from Whole Foods Market on March 17, 2016, in which the senior leadership stated they take FDA’s observations seriously and will work to correct them. FDA was not satisfied. “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,” states the agency. “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.”
FDA also cited its authority to collect fees from Whole Foods Market to cover the cost of re-inspection. Given 15 days to respond, Whole Foods Market released a statement saying that it had corrected each of the issues found by FDA. “We were honestly surprised,” said Ken Meyer, executive vice president of operations for Whole Foods Market in the statement. “We’ve been in close contact with the FDA, opened our doors to inspectors regularly since February and worked with them to address every issue brought to our attention.”