As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Bakkavor Foods USA Inc.
Charlotte, NC

A food firm in North Carolina is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis and Risk-based Preventive Controls for Human Food regulation including the presence of Listeria monocytogenes in their facility.

In an Aug. 8, 2022, warning letter the FDA described a Feb. 7-11, 15 and 23, 2022, inspection of Bakkavor Foods USA Inc.’s ready-to-eat (RTE) dips, soups, salad bases, burritos, entrée style meals and seafood products manufacturing facility.

The FDA’s inspection revealed that the ready-to-eat products manufactured in the firm’s facility are adulterated. The inspection resulted in the issuance of an FDA Form 483. Some of firm’s significant violations are as follows:

Hazard Analysis and Risk-based Preventive Controls:

1. The firm did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control.

Listeria monocytogenes in the facility:

To underscore the Listeria monocytogenes risk in the firm’s facility: FDA’s environmental findings indicate that they have a resident strain of Listeria monocytogenes in their facility, as well as transient strains.

FDA laboratory analysis of environmental sample 1171734 collected on Feb. 8, 2022, from various areas in their processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed fourteen (14) of one-hundred ten (110) environmental swabs were positive for L. monocytogenes. These locations include areas wher products are exposed to the environment prior to packaging in their production room, (redacted) room, work in progress cooler, and (redacted) room. This was not the first time L. monocytogenes was found in environmental samples collected at their facility.

Environmental swabs collected also revealed L. monocytogenes in this facility as follows:

• 2019, four out of 105 swabs collected by the North Carolina Department of Agriculture & Consumer Services (NCDA) from non-food-contact surfaces, including the floors and drains
• 2016, eight out of 178 swabs collected by NCDA from non-food-contact surfaces, including the floors and drains
• 2009, six of 40swabs collected by FDA from non-food-contact surfaces, including the floors and drains
• 2008, eight of 50 swabs collected by FDA from non-food-contact surfaces, including the floors and drains.

Moreover, in reviewing their facility’s own environmental monitoring test results, the FDA noted that their have repeatedly found Listeria spp. through their own testing. For example, Listeria spp. was found in or on:

(1) The condensation lines and the floors beneath evaporators.

(2) The WIP cooler floor, including on the condensation line terminus and the floor drain.

(3) The food contact surface of the cheese grinder.

(4) The food contact surface of the (redacted) tumbler seal and the inside of the lid.

(5) The framework of the (redacted) line.

The firm’s Listeria spp. findings can, in part, be attributed to the insanitary conditions observed during the inspection.

Current Good Manufacturing Practice:

1. The firm did not clean and sanitize equipment in a manner that protects against contamination of food-contact surfaces, as required.

Specifically, during the Feb. 2022 inspection FDA investigators observed (redacted) hose nozzles, used for rinsing RTE food contact equipment, stored on the floor: in the (redacted) area, between the (redacted) lines in the production room, next to a trash cart in the production room, and in the kettle room. On Feb. 10, 2022, an employee used a nozzle from the floor to clean/rinse the depositor pump parts that were stored on a prep table in the staging area of the processing room, then return the hose to the floor. The parts were subsequently sprayed with sanitizer, but in a manner that did not adequately coat all food-contact surfaces. The firm routinely collect Listeria spp. positive swabs from floors and drains throughout their facility, including at least (redacted) in 2021-2022.

2. The firm’s plant is not constructed in such a matter that drip or condensate from fixtures, ducts and pipes does not contaminate food and food-contact surfaces, as required.

Specifically, FDA investigators observed excessive condensation on the ceiling and evaporators throughout their facility directly above RTE product and food-contact surfaces, including in the WIP cooler and over unprotected, cleaned, and sanitized RTE food-contact bins in the (redacted) washroom. Also, condensation was observed on the ceiling above the (redacted) hopper for the (redacted) machine wher RTE (redacted) and (redacted) are manufactured.

3. The firm did not conduct all food manufacturing and processing under such conditions and controls as are necessary to minimize the potential for contamination of food, as required.

Specifically, FDA investigators observed that while walking across the floor of the WIP cooler, employees splashed pooled water onto trays of in-process RTE food (prior to packaging) stored on rolling racks in the cooler. The pooled water appeared dirty and contained food residue.

4. The firm’s plant equipment and utensils used in manufacturing and processing are not designed and of such material and workmanship as to be adequately cleanable, and adequately maintained to protect against contamination, as required.

Specifically, FDA investigators observed apparent rust on the food-contact parts of the Cheese Grinder (redacted) and its outlet port. They also observed that the (redacted) on the (redacted) tumblers which hold RTE food were damaged, making them difficult to clean.

5. The firm did not clean non-food-contact surfaces of equipment used in the operation of a food plant in a manner and as frequently as necessary to protect against contamination of food and food contact surfaces, as required.

Specifically, FDA investigators observed apparent food residue remaining on the inside cup holder framework of the (redacted) machine wher RTE (redacted) and (redacted) dip are packed, as well as on the conveyor belts and framework for (redacted) lines (redacted), after pre-op inspection and release by quality assurance on Feb. 10, 2022. They also observed apparent old and fresh product and black residue on the wheels of the conveyors for the (redacted) line and the (redacted) lines after pre-operation inspection and release by quality assurance on Feb. 10, 2022. The wheels contact the outer/food-contact surface of the belts.

Seafood HACCP:

1. The firm must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points.

However, the firm’s HACCP plan fails to list a CCP for finished product storage of their RTE seafood products to control the hazards of pathogen growth and toxin formation including Clostridium botulinum, and histamine formation. This is a repeat violation that was noted in the firm’s 2010, 2012, 2015, and 2019 inspections.

FDA investigators observed several deviations of refrigerated finished product storage and implementation of the firm’s written temperature control procedures as follows:

• The finished product cooler continuous temperature monitoring device had been disconnected since (redacted), management was unaware, and the records are not reviewed by quality assurance. The tuna salad and hot filled soups are stored in this cooler for up to (redacted) to shipping.
• Review of the firm’s finished product cooler temperature monitoring logs from Sept. 2021 found approximately (redacted) out of (redacted) temperatures documented over (redacted)F. These records also indicated that the recorded temperatures were frequently in the range of (redacted)°F for (redacted) with a maximum of (redacted). Additionally, their shipping records indicate that they manufactured and stored their RTE tuna salad in the finished product cooler with these temperature deviations for (redacted) to (redacted) days in Sept. of 2021. Finally, the firm did not have any corrective actions to ensure unsafe product was not distributed and their HACCP plan was reassessed as required.
• The finished product cooler temperature was not rechecked within (redacted) hours after exceeding (redacted)°F according to the firm’s procedures on the following dates: (redacted). The records were reviewed by QA; however, no deviations were noted.
• The firm did not visually monitor the temperature of the finished product cooler (redacted) according to their procedure, wher tuna salad and hot filled soups may be stored for up to (redacted), on the following dates: (redacted).

The full warning letter can be viewed here.

El Gordo Spices LLC
Dallas, TX

A food firm in Texas is on notice from the FDA for serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

In a Sept. 30, 2022, warning letter the FDA described a July 7-15, 2022, inspection of El Gordo Spices, LLC’s herbs, spice and seafood repacking and warehousing facility in Dallas, TX.

The FDA’s inspection revealed that the firm was not in compliance with HACCP regulation and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

Seafood HACCP:

1) The firm must have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur. A food safety hazard is defined as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, the firm’s Seafood HACCP plan for shelf stable RTE Whole Dried Shrimp and Ground Dried Shrimp products do not list the food safety hazard of allergens. Shrimp is a known allergen. Additionally, the firm does not have an allergen program.

2) The firm must take an appropriate corrective action when a deviation from a critical limit occurs. The firm did not take a corrective action to control sulfiting agents when their process for RTE Whole Dried Shrimp deviated from their critical limit at the receiving product critical control point. The firm’s Seafood HACCP plan identifies sulfiting agents as significant hazard at a receiving product step. The Critical Limits for each Preventive Measure states, “Incoming lots of RTE Whole Dried Shrimp must be accompanied by a lot by lot certificate stating sulfating agents were not used.” The firm’s management provided “(redacted) Specification Sheet” as a lot certificate which states, “May or May Not Contain Sulfites”. According to their Seafood HACCP plan, the corrective action when a deviation from a critical limit occur is to “Test the Lots for sulfiting agents. Reject the lot if (redacted) ppm or greater.” The firm was unable to provide testing results for sulfiting agents during the inspection.

Misbranded Foods

3) The firm’s products Ground Dried Shrimp, Whole Dried Shrimp, Sesame Seeds, and Textured Soybeans are misbranded because their labels fail to bear nutrition information (e.g. Nutrition Facts labels), as required.

4) The firm’s Ground Dried Shrimp, Whole Dried Shrimp, Ground Cumin, Whole Bay Leaves, Sesame Seeds, and Textured Soybeans products are misbranded because the product labels contain information in two languages, but does not repeat all the required information in both languages as required. For example, “net weight” or “net wt.” must be declared in both languages, and the Ground Dried Shrimp, Whole Dried Shrimp, and Textured Soybeans labels lack an ingredient statement in the foreign language.

5) The firm’s Ground Dried Shrimp product is misbranded because the product contains artificial coloring and fails to bear labeling stating that fact. The firm’s supplier’s specification sheet for the bulk dried shrimp states that it contains FD&C Red #40 Lake. However, their finished product label for the Ground Dried Shrimp product does not declare color additive FD&C Red No. 40 Lake as required.

The full warning letter can be viewed here.