The Food and Drug Administration recently sent warning letters to a baked goods manufacturer in New York, a ready-to-eat (RTE) food manufacturer in Georgia, and livestock auctioneer in Ohio, 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.
Inspectors found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) in addition to misbranding; “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 Sept. 6, 2019, to the baked goods manufacturing facility owners Mr. Yuriy (NMI) Normatov and Ms. Zoya (NMI), informing them of multiple violations after inspecting the facility from April 9 through April 25, 2019. The facility manufactures Ready-to-Eat (RTE) bakery products, including doughnuts and pastries. Additionally, the FDA noted a response form they received from the firm on May 26, and June 19, 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):
- During our inspection we determined that you did not prepare, or have prepared, and did not implement a food safety plan (FSP) for the food manufactured in your facility, such as RTE doughnuts and pastries, as required by The Act;
- In the firm’s response dated June 19, 2019, they submitted their draft FSP that includes a hazard analysis for food products manufactured in their facility, however, the FDA noted that the firm’s FSP only has process controls (frying/baking) for microbial hazards, and does not indicate that they use preventive controls such as sanitation controls to significantly minimize or prevent food allergens; and
- For example, “all your Danishes are listed in your production schedule as ‘Order #3’; your Danishes include one variety with a unique allergen – pecan (in honey pecan Danish) – which would require a different schedule from the varieties that do not contain pecan unless sanitation controls are used to prevent cross-contact of the fruit Danish by the honey pecan Danish.”
- Current Good Manufacturing Practice (Subpart B):
- The firm did not take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests;
- For example, “At 10:15 AM, five (5) live apparent juvenile rodents were observed in an apparent rodent nest in the Northeast corner of the packaging room in the bottom-most cardboard box within a stack of cardboard boxes used as packaging material for RTE doughnuts.”;
- Additionally, “Two pest stations were observed directly on the doughnut machine,” and, “Live cockroach-like insects TNTC (too numerous to count) were observed in the oven control panels located in the oven room where work in process and finished food products were being stored and handled.”;
- The FDA observed, “Open and closed bags of ingredients in the dry storage areas, including pallets of doughnut dry flour mix, powdered sugar, and buckwheat were noted as having apparent REPs TNTC on and around the bags.”; and
- Also, “Plastic bins used to hold icing had plastic lids and an accumulation of filth and mold-like matter on the inside surface of the lid was observed.”
- Color Additive Labeling:
- “Specifically, according to your draft FSP, your Cake Donut and Yeast Donut products are manufactured with FD&C Yellow No.5; however, the products do not bear a label identifying the presence of this color additive.”
- All of the firm’s products, including but not limited to all varieties of donuts, scones, muffins, Danish, and turnovers, are misbranded in that the finished product labels fail to declare all major food allergens.
- Specifically, the firm’s products are manufactured with wheat, milk, egg, soy, almonds, walnuts, coconut, and/or pecans in various combinations; “You package all of your products into cardboard boxes with a statement that “This product contains: Eggs, Milk, soy, wheat and tree nuts” regardless of the contents within. Further, the use of the term “tree nuts” is not permitted in the “contains” statement. The actual food source for the allergen must be listed.”; and
- “All of your products, including but not limited to all varieties of donuts, scones, muffins, Danish, and turnovers, are misbranded in that the product labels fail to include the place of business of the manufacturer, packer, or distributor.”
- Food Facility Registration:
- The FDA has determined that the firm’s facility is subject to the food facility registration requirement; “Our records indicate that as of the date of this letter your registration was canceled. The failure to register a facility as required is a prohibited act.”
The full list of violations observed by the FDA can be found in the complete Warning Letter, here.
Flying Food Group LLC — Lawrenceville, Georgia
Inspectors found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, including the presence of Listeria in the facility; “Based on FDA’s inspectional findings, we determined that your 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. 12, 2019 to the ready-to-eat (RTE) food manufacturing facility CEO, David Cotton, informing him of multiple violations after inspecting the facility from February 25 through March 6, 2019.
“During the inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strain found during FDA’s 2018 & 2017 inspections.”
Several other signifiant violations include:
- The firm did not appropriately evaluate environmental pathogen, specifically, “You manufacture RTE foods that are exposed to the environment at several steps (e.g., meat slicing, produce cutting, batching, assemble product) where the food could be contaminated with environmental pathogens, such as L. monocytogenes, and the food does not receive a subsequent control for environmental pathogens.”;
- The FDA collected eleven environmental swabs during their most recent inspection, which were positive for L. monocytogenes. Of the eleven positive swabs, five swabs were collected from food contact surface areas, and six swabs were collected from areas adjacent to food contact surface areas;
- “Furthermore, environmental swabs collected during our 2018 inspection revealed L. monocytogenes in three swabs within your facility, and environmental swabs collected during our 2017 inspection revealed L. monocytogenes in one swab within your facility. Whole genome sequencing (WGS) of isolates detected in the FDA environmental samples determined that the fifteen isolates collected during the 3 most recent inspections contain the same strain of L. monocytogenes.”
- The FDA noted that the presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen in your facility since 2017;
- “These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. Once L. monocytogenesis established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product,” and, “It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.”;
- The firm did not clean your utensils or equipment as frequently as necessary to protect against allergen cross-contact and contamination of food, for example, “Exposed slices of meat were observed being stored on and in contact with the sides of a stainless-steel rack that contained visible debris.”;
- The firm did not take reasonable measures and precautions to ensure that gloves used in food handling were maintained in an intact, clean, and sanitary condition;
- The firm did not identify undeclared allergens and allergen cross-contact as a known or reasonably foreseeable hazard requiring a preventive control; and
- The FDA also noted that, “In addition, to control pathogen growth and or toxin formation due to a lack of time and temperature control during distribution, it is important to consider the significance of these hazards in your process and to determine whether or not a preventive control during distribution is required for food safety.”
The FDA reminded the firm that they are responsible for ensuring that their facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws, and that they should take prompt action to correct the violations noted in this letter; “Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure.”
In a Sept. 6 warning letter to owner Leroy H. Baker, Jr., the FDA described violations observed during inspection visits on April 29 – 30, and June 24, 2019 at the Sugarcreek Livestock Auction, located at 102 Buckeye Street SW, Sugarcreek, Ohio. Investigators found that the firm holds animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.
For example, the firm failed to maintain treatment records. In addition, the firm admitted medicating animals they deal and transport for sale at auction, but were not able to provide documentation that shows they are notifying buyers that animals are medicated. The FDA noted that firm also lacks an adequate system to identify and segregate animals that have been medicated. The inspection documented that bottles of the ceftiofur containing animal drugs “(undisclosed)” had disposable syringes stored in the bottles; “The syringes appeared to contain medication residues from being used and were dirty.” Food from animals held under such conditions is adulterated.
According to the warning letter, the FDA noted that the firm stated they have a verbal agreement to prophylactically medicate all animals that they routinely sell to three dealers. “It does not appear that medications you are using were prescribed to you for use at your firm,” the FDA said. “Please note that the extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label use complies with Sections 512(a)(4) and (5) of the FD&C Act, 21 USC 360b(a)(4) and (5), and 21 Code of Federal Regulations Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.”
The FDA warned that the firm should take prompt action to correct the above-referenced violations and to establish procedures to ensure that these violations do not recur. Furthermore, “Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.”
As of the posting of the warning letter, the FDA has not received a response to the Form FDA 483 issued on June 24, 2019.
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