A bakery is on notice from the FDA because the firm’s products were prepared, packed, or held under conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.
Staff from the Food and Drug Administration inspected the Olympia, WA, location of Blue Heron Bakery from Nov. 28 through Dec. 6, 2017, and discovered “serious violations” of the Current Good Manfacturing Practice (cGMP) regulation for foods, according to a March 23 warning letter made public by the FDA in recent days.
Specifically, FDA District Director Miriam R. Burbach noted the following observations logged during the inspection:
- The firm failed to take effective measures to exclude pests from their processing areas and to protect against contamination of food on the premises by pests. Specifically, FDA investigators documented evidence of rodent activity near food storage and preparation areas in the food processing facility:
- Specifically, on Jan. 26, 2018, eight Rodent Excreta Pellets (REPs) were observed on the floor behind the mixer along the north wall, west of the three compartment sink and east of the ingredient batching station;
- Eight REPs were observed on plastic bin lids and on a wood block stored under the dough roller in the southeast corner of the production area, approximately one foot from the dry ingredient storage rack and west of the exit. This area houses the ingredient storage rack and dough proofers;
- Three REPs were observed in the frame of the dough roller located west of the exit in the southeast corner of the facility;
- Three REPs were observed on the floor along the south wall in the southeast corner of the facility and approximately six inches from the dry ingredient storage rack;
- Two REPs were observed on the floor in the southeast corner of the facility and on the east side of the commercial oven;
- Seven REPs were observed on the floor along the east wall of the facility behind the dishwasher; and
- Thirteen REPs were observed on the floor along the east wall of the facility, under and behind a rolling metal cart approximately two feet to the south of the commercial dishwasher. Clean bread loaf pans are stored on this rolling metal cart;
- Two REPs were observed on the water heater support shelf above the utility sink in the storage room off the north side of the production area.
“FDA sample INV 1037887, collected on Jan. 25, 2018, during the current inspection, was analyzed by FDA’s Pacific Northwest Laboratory. The analysis of this sample confirmed the presence of REPs and confirmed the presence of rodent activity within your facility,” according to the warning letter.
- The firm failed to provide adequate screening or other protection against pests, specifically, the rear exterior door to the facility was propped open to the outside each day of the inspection without adequate protection to prevent entry of pests into the production facility;
- The firm’s employees failed to wear hair restraints and beard covers where appropriate, specifically, the FDA investigator observed two employees with facial hair working in the production area, handling in-process wholesale breads and cookies, without beard covers or hair nets;
- The firm’s employees failed to adequately store personal belongings so that they were not in an area where food is exposed and equipment or utensils are washed, as required by 21 CFR 110.10(b)(7). Specifically,
- The FDA investigator observed an employee’s coat hanging from an empty bread cooling rack in the production area;
- The FDA investigator observed an employee’s coat, and two uncovered beverage containers on the north corner of the prep island in the food production area; and
- The FDA investigator observed a set of keys, two uncovered beverage containers, and an employee’s personal food item on the north corner of the prep island in the production area. An employee was observed pureeing vegetables on the same prep island approximately one foot away from these articles.
Several of the above observations were noted as “repeat observations.”
The FDA noted no response letter from the firm; “FDA issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. We have not received any correspondence from your firm in response to the FDA-483s.”
Food companies are given 15 working days to respond to FDA warning letters. “You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction,” according to the warning letter.
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