The U.S Food and Drug Administration found serious violations — including Listeria — at a “multiple food manufacturing facility,” owned by Whole Foods Markets Inc., according to a warning letter posted today. FDA sent the letter about the Everett, MA, “factory kitchen” to Austin, Texas -based Whole Foods on June 8, but did not order the company to cease operations there. Whole Foods calls the facility its North Atlantic Kitchen. During an inspection of the facility in February, the agency found numerous violations of current Good Manufacturing Practices (GMP) and the federal Food, Drug and Cosmetic Act. FDA said foods manufactured at the facility — pesto pasta, mushroom quesadilla, vegetables, chives and beets, ready-to-east egg salad — were being “prepared, packed or held under insanitary condition whereby they may be have been contaminated with filth or rendered injurious to health.” The warning letter said the Whole Foods facility was failing to take steps to control the growth of microorganisms and contamination and cited several examples. It further said Whole Foods failed to maintain equipment. FDA inspectors took 100 environmental samples on food contact surfaces and non-food contact surfaces in the Whole Foods facility and found Listeria on food contact surfaces. FDA said those findings were “an indicator for the probable presence of Listeria monocytogenes in your processing environment.” “This finding demonstrates that conditions exist in and on your equipment that would support the presence and growth of Listeria monocytogenes and indicates that your cleaning and sanitation practices may not be adequate,” said the warning letter. Inspectors specifically noted employees splashing dirty water on to ready-to-eat vegetables while washing their hands, condensation dripping into barrels of egg salad and onto food preparation surfaces while employees were chopping vegetables there, and overspray from a bottle of ammonium-based sanitizer landing on an open colander of salad leafy greens. The Whole Foods facility also lacked hand adequate washing facilities and inspectors found an unmarked drum of chemicals in the vegetable prep area. Officials with Whole Foods responded to the inspector observations, saying the company takes the concerns seriously and promising senior leadership would take all necessary measures to correct the deficiencies. The warning letter, however, found that was not enough. “We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted correction actions have been effectively implemented, said the warning letter. The kind of documentation FDA is looking for includes photographs, invoices, work orders, voluntary destruction records of any affected products, and contractor certifications. Whole Foods has 15 days to respond and will likely have to pay for any re-inspections. Some of the other specific violations observed by FDA inspectors were:
- On February 10, 2016, you were mixing ready to eat pesto pasta directly under an area in the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
- On February 16, 2016, you were storing an uncovered rack of ready to eat mushroom quesadilla in the same area of the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
- On February 10, 2016, your employee transported uncovered ready to eat vegetables through a doorway, from the Veg Prep Room into the Prepared Veg Cooler. A significant amount of condensate had formed above the doorway and was dripping onto the surface below.
- On February 10, 2016, your employee was cutting chives and beets on a work surface directly underneath a leaking condensate drainage pipe in the Veg Prep Room.
- On February 16, 2016, you were holding uncovered ready to eat egg salad in large white barrels that were placed in an area below the condenser. Condensate was observed to be dripping at a rate of approximately once per second from the condenser fan bolts in the K8/K9 Room.
- On February 16, 2016, your employee transported uncovered ready to eat couscous through an area in the K8/K9 Room where condensate was dripping from an area around the condenser fan bolts at a rate of approximately once per second.
- On February 10, 16, & 18, 2016, you were holding ready to eat vegetables, utensils such as cutting boards, mandolins, stainless colanders and yellow plastic totes in close proximity to hand a washing station in the Veg Prep Room. The hand washing station does not have splash guards and is foot operated releasing water from the faucets with significant pressure causing water to splash outside the sink while employees were observed washing soiled hands. Water splashed onto covered and uncovered ready to eat vegetables, utensils and food containers.
- On February 16, 2016, your employee measured the strength of peracetic acid from the faucet in the Veg Prep Room with an … Peracetic Acid test strip that indicated its strength over 160 ppm (maximum level on the test strip). This concentration exceeds the maximum level recommended by the … product information sheet and the maximum level allowed under 21 CFR Part 173.315(a) (5) for use of peracetic acid for surface treatment and soaking and rinsing of vegetables.
- On February 16, 2016, your employee was performing multiple tasks in the Pre-Pack Room including filling and weighing ready to eat egg salad in retail packs. The employee was observed cleaning and directly contacting work surfaces and then packaging and handling exposed product without hand washing or changing gloves in between tasks.
- On February 16, 2016, your employee in the Bulk-Pack Room was observed assembling bulk cartons while also packaging exposed ready to eat quinoa cakes without hand washing or changing gloves in between tasks.
- On February 16, 2016, your employee in the Pre-Pack Room was spraying … quaternary ammonium based sanitizer to clean work surfaces while another employee in close proximity was packaging exposed ready to eat mesculin salad. This resulted in the sanitizer being sprayed onto an open colander of salad leafy greens.
- On February 16, 2016, your employee’s unprotected upper sleeves were frequently touching ready to eat leafy salad greens as leafy salad greens were packaged into retail packs in the Pre-Pack Room.
Note on corrected content: The original version of this story incorrectly identified the type of Listeria found by inspectors. Only non-pathogenic Listeria was detected at the facility. (To sign up for a free subscription to Food Safety News, click here.)