Six companies put on notice after FDA uncovers violations

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.

Martinez Mexican Produce LLC

Hidalgo, TX

Fides Ny Inc.

Bayside, NY

Grupo Rm Usa, Inc.

Miami, FL

La Sonorense, Inc.

Phoenix, AZ

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

1. The firm did not identify and evaluate undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control. Their facility receives, stores, and manufactures products that contain an allergen (wheat). FDA investigators observed their RTE pressed wheat flour tortillas were packaged into clear unlabeled packages, twist tied closed, and packed into a cardboard box. The bulk packaged RTE pressed wheat flour tortillas were not labeled with an ingredient statement declaring wheat flour as an ingredient. As a result of FDA inspection, their firm conducted a voluntary recall of their bulk Pressed Wheat Flour Tortillas that contain wheat flour as an ingredient due to undeclared wheat allergen on the product label.
2. The firm did not identify and evaluate bacterial pathogens such as pathogenic E. coli, Salmonella, and Listeria monocytogenes in their ingredients as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. For example, pathogenic E. coli and Salmonella are known or reasonably foreseeable hazards in flour.
3. The firm did not identify and evaluate environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard after their (redacted) step to determine whether the hazard requires a preventive control. Their facility manufactures RTE food which is exposed to the environment after the (redacted) step but prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure, such as a formulation lethal to the pathogen or control by the supply chain or downstream customer, that would significantly minimize the pathogen.
4. They did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control. Their facility manufactures tortillas with wheat and corn flour. These ingredients have been associated with mycotoxins.

1. The written hazard analysis.
2. The written preventive controls.
3. The written supply-chain program.
4. The written corrective action procedures.
5. The written verification procedures.

Current Good Manufacturing Practice (Subpart B):

• The firm did not take effective measures to exclude pests from their manufacturing, processing and packing areas to protect against the contamination of food, as required by 21 CFR § 117.35(c). Specifically, the FDA investigator observed:

• The firm’s equipment and utensils were not adequately maintained to protect against contamination. Specifically, on March 17, 2020, FDA investigators observed the plastic and metal portions of the belt on the feeder of the (redacted) Tortilla oven and (redacted) Tortilla oven were scarred and stained with  dark residue. A similar observation was made during the 2018 inspection. Their written response did not address this violation.
• The firm did not clean and sanitize its utensils or equipment in a manner that protects against contamination. Specifically, FDA investigators observed their sanitation process, which consisted of scraping to remove residual dough and wiping down the RTE tortilla processing areas using a cleaner/degreaser in (redacted) water and a rag (redacted), but no sanitizer. Residual dough, approximately ¼ inch thick on the mixer, proofing boxes, metal sheet pans, and dough feeders, was observed after cleaning was performed. The large metal vat used to soak, and boil corn kernels contained standing water and had yellow and brown stains with residues measuring approximately ½ inch thick on the food contact surfaces. An employee used a metal scoop to remove standing water from the metal vat, but the vat was never cleaned prior to being used in food production. Furthermore, the (redacted) conveyors used to transport the baked tortillas to packaging were not cleaned. Similar observations were made during the 2018 and 2019 inspections.

Grand Strand Sandwich Company Inc.,

Longs, SC

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

• In their food safety plan, they identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of Listeria monocytogenes in their facility, they did not implement sanitation controls adequate to ensure that their facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen Listeria monocytogenes.

• Their environmental monitoring procedures are not adequate. Specifically, their “Environmental Sampling-(redacted) & In-house,” dated Feb. 26, 2020, states that for their “(redacted)-Done (redacted)” they will “collect (redacted) swabs from different locations in our production room, place swabs and paperwork in cooler with ice pack, Ship to (redacted), place report in Environmental Sampling Book.” Additionally, for their “In House Testing-Done,” they will “collect (redacted) swabs from different locations in our production room, place in incubator, record results.” The firm’s environmental monitoring procedures for both their external laboratory analysis and in-house testing do not identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring; or identify the test(s) conducted.

Chicago Indoor Garden Inc.

Chicago, IL

Pathogen Findings

Produce Safety Regulation Violations

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