Over five visits in February, the FDA said inspectors documented the findings at Whole Foods’ North Atlantic Kitchen facility.
Products were “prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health,” the FDA said in the letter released Monday. The agency “has serious concerns that our investigators found your firm operating under these conditions.”
Whole Foods Market Dayton opened one year ago in Washington Twp. at 1050 Miamisburg-Centerville Road.
The company said Tuesday it has already addressed and corrected the FDA concerns through “thorough and tangible steps” and contacted the agency to discuss why those fixes weren’t reflected in the FDA’s letter.
“We were honestly surprised,” said Ken Meyer, Whole Foods’ global executive vice president of operations. “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.”
The news on Tuesday put pressure on the retailer’s stock, sending it down 2.9 percent or 97 cents to close at $32.52.
Bill Marler, a Seattle-based lawyer who is an expert on foodborne-illness cases, said the FDA’s warning to Whole Foods is part of a larger focus on listeria concerns after several high-profile cases, including last year’s Blue Bell Creameries outbreak.
Marler said the FDA’s findings could impact Whole Foods the same way an E. coli outbreak recently hurt Chipotle Mexican Grill.
“Whole Foods like Chipotle has created a market niche for itself,” Marler said. “If you are going to live on the edge and tout yourself as a wholesome, safe alternative and something goes wrong, it’s going to impact you more.”
The FDA said it issued its initial observations to Whole Foods on Feb. 26. Whole Foods responded on March 17 and said it would take the findings seriously, but the FDA said the company needed to do more, such as provide documentation showing fixes.
Among other issues, the FDA said, Whole Foods failed to manufacture, package and store foods under conditions that would minimize contamination risks. For example, on Feb. 10, an inspector observed a ready-to-eat pesto pasta being prepared in an area below leaky condensation.
The agency said Whole Foods also failed to maintain equipment and surfaces with required cleaning and sanitizing efforts and its hand-washing facilities “lack running water of a suitable temperature.”
Finally, the agency said Whole Foods failed to properly identify toxic sanitizing agents. For example, an inspector saw an unmarked drum of a chemical near a vegetable prep sink.
Whole Foods will be required to respond within 15 days or potentially face sanctions, such as a closure of the facility, the FDA said.
“It is your responsibility to assure your establishment is in compliance,” the FDA said. “You should take prompt measures to correct all violations described in this letter.”
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