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. The FDA frequently redacts parts of warning letters posted for public view.


The Famous Lartigue Seafood
Fairhope, AL

A food firm in Alabama is on notice from the FDA for serious violations of Seafood Hazard Regulations.

In a Dec. 13 warning letter, the FDA described an Oct. 19-20 and 25, 2021, inspection of The Famous Lartigue Seafood processing facility in Fairhope, AL.

The FDA’s inspection revealed that the firm was not in compliance with FDA regulations, resulting in the issuance of an FDA Form 483.

The significant violations were as follows:

  1. The firm must conduct or have conducted a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and they must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur. However, the firm does not have a HACCP Plan for fresh sushi-grade salmon to control parasites and environmental hazards.
  2. The firm must maintain sanitation control records that, at a minimum, document monitoring and corrections. Specifically, they do not have sanitation control records that document the monitoring of the following key areas of sanitation: Condition and cleanliness of food contact surfaces, such as tables and utensils. Prevention of cross-contamination from insanitary objects. Maintenance of handwashing, hand sanitizing, and toilet facilities. Protection of food, food packaging material, and food contact surfaces from adulteration. Proper labeling, storage and use of toxic compounds. Control of employee health conditions.
  3. To comply with regulation, the firm must have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing that is at least equivalent to that received under a standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who may otherwise be qualified through job experience to perform the following functions: 

(1) the development of the HACCP plan,

(2) the reassessment and modification of the HACCP plan in accordance with the corrective action procedures,

(3) the reassessment and modification of the HACCP plan in accordance with the verification activities,

(4) the reassessment and modification of the hazard analysis in accordance with the verification activities,

(5) perform the record review.

The full warning letter can be viewed here.

Sarita’s Tortilla Factory, Inc.
Eagle Pass, TX

A food firm in Texas 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.

In a Nov. 22 warning letter, the FDA described a July 7-12, 2021 inspection of Sarita’s Tortilla Factory food manufacturing facility in Eagle Pass, TX.

The FDA’s inspection revealed that the firm was not in compliance with FDA regulations, resulting in the issuance of an FDA Form 483.

Some of the violations:

Hazard Analysis and Risk-Based Preventive Controls:

  1. The firm did not prepare, or have prepared, and implement a food safety plan. The preparation of the food safety plan must be overseen by their preventive controls qualified individual (PCQI) and must include the following:

(1) A written hazard analysis.

(2) Written preventive controls,

(3) A written supply-chain program, 

(4) A written recall plan,

(5) Written procedures for monitoring the implementation of the preventive controls,

(6) Written corrective action procedures,

(7) Written verification procedures.

  1. The firm did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at their facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring preventive control. Specifically:
  2. The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring preventive control. Their facility manufactures soft flour tortillas (which contain allergens including wheat and whey (milk)) and soft corn tortillas (which do not contain allergens) in the same production area, using shared utensils.
  3. The firm did not identify and evaluate environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether they are a hazard requiring preventive control. Their facility manufactures RTE soft flour and corn tortillas which are exposed to the environment after they exit their respective ovens and are cooled on the cooling conveyors prior to packaging. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen that would significantly minimize the pathogen). Note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring preventive control.
  4. The firm did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they are a hazard requiring preventive control. Their facility manufactures soft flour and corn tortillas using wheat flour and cornflour. These ingredients have been associated with mycotoxins such as deoxynivalenol (DON) and aflatoxin, respectively.
  5. The firm did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system.

Current Good Manufacturing Practice:

  1. The firm did not maintain buildings, fixtures, and other physical facilities of their plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated. Specifically, FDA investigators observed the following:
  2. Water was dripping from a ceiling with peeling paint onto a pallet of (redacted)(redacted) bags of flour.
  3. Filth was present on metal air vents and fans located directly above RTE soft flour and corn tortillas. The fans are used to cool the tortillas after cooking.
  4. The firm did not ensure that their cleaning compounds and sanitizing agents are safe and adequate under the conditions of use. Specifically, during the inspection, FDA investigators observed the following:
  5. Employees were not monitoring sanitizer solutions and were using (redacted) sanitizer at a concentration of less than the manufacturer’s recommendation (redacted) on a food contact surface. Specifically, when an FDA investigator tested with test strips (redacted) solutions that were intended to sanitize the (redacted) mixer, the concentration was found below 10 ppm and 100 ppm for the two solutions.
  6. Employees did not allow the sanitizers to adequately air-dry after being sprayed onto food-contact surfaces, as directed by the manufacturer’s directions. The firm’s PCQI explained that they do not allow the sanitizer to air dry, instead their firm wipes off the sanitizer after it has been applied.
  7. The firm did not identify sanitizing agents in a manner that protects against contamination. Specifically, unlabeled containers/bottles containing unknown substances were observed being used on the tortilla oven conveyor belts, which are food-contact surfaces. According to the firm’s PCQI, some containers/bottles contained non-stick agents, and others contained sanitizer solutions.
  8. The firm did not take effective measures to exclude pests from their food plant to protect against contamination of food. Specifically, on July 7, 2021, FDA investigators observed the following:
  9. Several live insects were crawling and flying inside the production room.
  10. A live frog was inside the raw ingredients room, under a pallet of wheat flour. The frog was observed to enter the facility through a gap in the loading bay door.
  11. An unscreened door was open at the north side of the facility during the production of soft flour and corn tortillas.
  12. There were gaps along two screened doors located in their facility’s loading areas on the northeast side and west side of the building.
  13. The firm did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food. Specifically, during the inspection, FDA investigators observed:
  14. Production employees inserted an approximately 12-inch piece of splinted wood into corn tortilla dough prior to the corn tortilla dough being placed into the pressing machine and manufactured into soft corn tortillas. In addition, another piece of wood with red residue was observed in a nearby tool/equipment box. An employee explained that this piece of wood was used on July 7, 2021, for red corn tortilla dough.
  15. Production employees used non-food-grade grease on tortilla production equipment, specifically on metal parts located directly above uncooked tortillas. The label states that the grease is intended for vehicle parts.

The full warning letter can be viewed here.

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