FDA Warns Company Over Flour Tortilla Production

The US Food and Drug Administration inspected a ready-to-eat (RTE) soft wheat flour tortilla manufacturing facility in Detroit, MI and sent a warning letter describing the issues found.

During the inspection at Hacienda Mexican Foods LLC from April 3-21, 2023, FDA investigators 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 the inspectional findings, FDA determined that the RTE soft flour tortillas manufactured in the facility were prepared, packed, or held under insanitary conditions and may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule. Also, the “SOY FREE” label claim is false or misleading, which causes your tortilla products that are labeled as such to be misbranded.

FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, and Hacienda responded to the inspection on May 5, 2023, and June 7, 2023, describing corrective actions taken or planned by your firm. After reviewing the inspectional findings and the responses that the tortilla manufacturing company provided, FDA found concerns and provided detailed information describing the findings at the facility in the letter.

FDA wrote:

Your hazard analysis for RTE soft flour tortillas did not identify and evaluate all known or reasonably foreseeable hazards to determine whether there are any hazards requiring preventive control.

Furthermore, you did not identify and evaluate recontamination with environmental pathogens, such as Salmonella, to determine whether it is a hazard requiring a preventive control in Hacienda’s RTE soft flour tortillas. Specifically, the firm’s written hazard analysis did not consider the hazard of recontamination with environmental pathogens.

The RTE tortillas are exposed to the environment prior to packaging where they could be contaminated with environmental pathogens such as Salmonella and do not receive a lethal treatment or otherwise include a control measure (such as formulation lethal to the pathogen) that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard, and a knowledgeable person manufacturing/processing food in your circumstances would identify recontamination with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation controls). Sanitation preventive controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens.

Your food safety plan, under the heading “Cleaning and Sanitizing Procedure” in the “Sanitation Preventive Controls” section, provides a general description of the facility’s cleaning and sanitation program components. These components do not identify any specific production equipment. The “Procedure” component references “Pre-op forms in process,” which was described by your Food Safety Assistant as the electronic spreadsheet titled “Cleaning and Sanitation Record” that your firm uses to document sanitation monitoring. However, this spreadsheet does not contain any written sanitation procedures or corrective action procedures.

The food safety plan and related procedures do not include adequate corrective action procedures that include steps to identify and correct the problem, reduce the likelihood the problem will recur, evaluation of all affected food for safety, and preventing all affected food from entering commerce if you cannot ensure food is not adulterated.

Further, an environmental monitoring program is a required sanitation verification activity for your RTE soft flour tortillas, as they are exposed to the environment prior to packaging. Your food safety plan, under the heading “Environmental Monitoring for Sanitation Control Verification,” includes references to a document titled “Microbial Control/Environmental Policy.” Your firm was unable to provide the “Microbial Control / Environmental Policy” and further stated that this policy was not implemented. Our investigators also noted that your facility only performs environmental sampling (b)(4) and only for Enterobacteriaceae (Eb). Eb is not a pathogen, and it is not an adequate indicator organism for the pathogen, Salmonella. As such, your firm’s environmental monitoring program is not verifying the effectiveness of your sanitation controls for Salmonella or other environmental pathogens.

In your responses, you identified a root cause of “SOPs were not printed and readily available” and you included nine undated written procedures for cleaning and sanitizing equipment. In addition, your responses identified a corrective action indicating that you would revise your food safety plan and retrain personnel. However, the version of the food safety plan included in your responses is the same as the version provided to our investigators during the inspection and, as such, it appears you have not reanalyzed your plan or made modifications that are necessary to correct this observation. Furthermore, your responses do not include employee retraining records. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

B. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require preventive control. Your facility manufactures RTE soft flour tortillas that contain wheat flour, which is an ingredient associated with mycotoxins such as deoxynivalenol (a.k.a. vomitoxin). A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring preventive control in this ingredient. A facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as vomitoxin in wheat flour, must establish and implement a risk-based supply-chain program for those raw materials and ingredients.

C. You did not appropriately identify and evaluate the hazard of “Survival of microorganisms due to low temperature” to determine whether it is a hazard requiring a preventive control for your RTE soft flour tortillas.