The Food and Drug Administration recently sent warning letters to a Massachusetts bakery, two seafood processing facilities in China and Greece because inspectors found significant violations of U.S. food safety laws at their operations.

Businesses have 15 days to respond in writing to the FDA after receiving a warning letter. If they don’t correct the violations, the FDA can take action up to and including shutting down operations.

Peggy Lawton Kitchens, Inc. — East Walpole, MA

Inspectors found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule); “Based on FDA’s inspectional findings, we determined that your RTE food products manufactured in your facility are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.”

The FDA sent a warning letter dated Aug. 29, 2019, to the bakery owner Mr. William H. Wolf, informing him of multiple violations after inspecting the facility May 28 through June 12, 2019, where the facility manufactures Ready-to-Eat (RTE) bakery products, including cookies and brownies. Additionally, the FDA noted a response form they received from the firm on June 21, 2019, including a summary of corrective actions taken and planned by the firm.

“The adequacy of each of your firm’s promised corrective actions is discussed below and implementation of those actions will be assessed during our next inspection,” the FDA said.

The violations noted by the FDA include:

• Hazard Analysis and Risk-Based Preventive Controls (Subpart C)
  • “The CGMP & PC rule requires that you must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control.”;
  • During the FDA’s inspection, it was determined that the firm did not prepare, or have prepared, and did not implement a food safety plan for the food manufactured in their ready-to-eat (RTE) cookie and brownie processing facility; and
  • The firm’s response outlines the corrective actions they have taken or plan to take, which includes modification of their recall plan; “Your response does not include a hazard analysis or food safety plan. We do not have enough information to fully assess your promised corrective actions regarding your violations of the requirements in subpart C. We will verify the adequacy of your corrective actions during a future inspection.”
• Current Good Manufacturing Practice (Subpart B):
  • “Your plant equipment and utensils used in manufacturing, processing, packing, or holding food are not designed and of such material and workmanship as to be adequately cleanable, and are not maintained adequately to protect against allergen cross-contact and contamination.”;
  • For example, multiple layers of electrical tape were observed wrapped around a cookie die. The cookie dough is pressed out of the die to make the dough in the shape of cookies;
  • “Specifically, on May 29, 2019, an employee was observed removing sheet pans of cooked brownies and placing them on a rack immediately beneath sheets pans of uncooked brownies. Additionally, your firm uses the same oven racks for holding sheet pans of uncooked brownies prior to placing the sheet pans in the oven and for holding pans of cooked brownies after they are baked.”; and
  • “On May 29, 2019, the equipment used to manufacture brownie batter was cleaned with water only; the cleaning did not include the use of detergent, physical scrubbing, and a sanitizer.”
• Additionally, the firm did not have records documenting training in the principles of food hygiene and food safety for employees who manufacture, process, pack, or hold brownies;
• “On May 29, 2019, and May 30, 2019, employees packaging ready-to-eat brownies were observed to not wash and sanitize their hands prior to handling brownies with their bare hands after touching unsanitary objects including dishwasher buttons with brown residue and conveyor belt switches that were observed to be encrusted with apparent brownie residue. The same employees were observed to not wash and sanitize their bare hands (or sanitize their gloved hands) after returning from break and continuing to work with the ready-to-eat brownies.”; and
• The firm did not adequately maintain buildings, fixtures, and other physical facilities in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated.
• Consumers can view a complete list of violations in the FDA warning letter.

Donggang Hongxing Food Co., Ltd. — Liaoning Sheng, China

In a warning letter dated Aug. 15, 2019, the FDA informed owner Quan Shijie that Donggang Hongxing Food Co.’s fish or fishery products were under serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. The FDA acknowledged receipt of the firm’s response sent via email on June 6, 2019 including a revised HACCP plan entitled “Frozen Boiled Short Necked Clam (Vacuum Packed)” and a spreadsheet outlining their corrections, however, FDA evaluation of the response revealed it was not adequate, as further described in the warning letter.

The firm’s frozen boiled short-necked clams (vacuum packed) are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.

The FDA noted the following significant deviations:

• The firm’s HACCP plan must, at minimum, list the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). “A critical limit is defined in 21 CFR 123.3(c) as ‘the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point, to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.'” However, the firm’s revised HACCP plan entitled “Frozen Boiled Short Necked Clam (Vacuum Packed),” dated June 1, 2019, lists critical limits that are not adequate to control pathogens because there is no corresponding critical limit for time.;
• The firm listed a critical control point that is not adequate to control Clostridium botulinum because it does not list that handling instruction is included on each label to state that the product is to be thawed under refrigeration. “FDA recommends each product label include the statement ‘Keep Frozen, Thaw under refrigeration immediately before use.'”; and
• The firm’s revised HACCP plan lists a critical control point and a monitoring frequency that is not appropriate to control natural toxins; “FDA recommends you visually check incoming tags of every container.”

Additional violations can be found in the FDA’s warning letter.

Pavlos Trifonidis S.A — Kavala, Greece

Pavlos Trifonidis S.A in Kava la, Greece is on notice from the FDA because of significant deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation under the Federal Food, Drug, and Cosmetic Act (the Act). The firm processes fish products, which must have a HACCP plan that complies with the Act.

FDA acknowledged receipt of an email response sent from the firm via email on April 5 and June 10, 2019; “Your responses included revised HACCP plans along with corresponding HACCP documents. However, our evaluation of your response revealed it was not adequate, as further described in this letter.”

Staff from the Food and Drug Administration inspected the firm’s facility on March 14 and 15, 2019, and rendered the firm’s tuna “Lakerda (Thunnus alalunga)” packed in oil and canned salted anchovies products adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

The FDA noted several significant deviations:

“The maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, the firm’s revised HACCP plan provided with their June 10th response for critical limit for a core temperature of the fish is not appropriate to control scombrotoxin (histamine) formation.

“FDA recommends a critical limit that ensures the product is held at a continuous cooler temperature of 40°F (4.4°C) or below, or ensure the product is completely and continuously surrounded by ice throughout the storage time.”

Additional critical limits submitted by the firm were not adequate by themselves to control scombrotoxin (histamine) formation when receiving fresh fish from the harvest vessel; In addition to taking the internal temperature of incoming scombroid species fish, FDA recommends conducting a sensory examination of a representative number of incoming fish for decomposition.

“Lastly, when processors rely on the adequacy of ice during transit from the harvest vessel to the plant, FDA recommends a critical limit that lists fish are to be completely surrounded by ice during transit and at the time of delivery.”

At the end of the warning letter, the FDA warned that if the firm does not respond, or if the FDA finds their response inadequate, further action may be taken; “For instance, we may take further action to refuse admission of your imported fish or fishery products.”

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