- Delivery Method:
- Food & Beverages
Recipient NameMaria X. Villarreal
Recipient TitleCEO and Co-Owner
- Sarita's Tortilla Factory, Inc
2505 El Indio Hwy.
Eagle Pass, TX 78852-5537
- Issuing Office:
- Office of Human and Animal Food Operations West Division 3
November 22, 2021
Dear Mrs. Villarreal:
The U.S. Food and Drug Administration (FDA) inspected your tortilla manufacturing facility, located at 2505 El Indio Hwy., Eagle Pass, TX 78852-5537 on July 7-12, 2021. This inspection covered your ready-to-eat (RTE) soft flour and corn tortilla manufacturing operation and was conducted as a follow-up to an inspection conducted at your facility on July 30-31, 2019. Both inspections revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) in Title 21, Code of Regulations, Part 117 (21 CFR part 117). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your firm.
Based on FDA’s inspectional findings, we have determined that the RTE tortilla products manufactured in your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been 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 (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's Internet home page at http://www.fda.gov.
FDA’s inspection on July 7-12, 2021, resulted in the issuance of a Form FDA 483, Inspectional Observations (FDA 483), listing deviations found during our inspection. We received your responses via email on July 26, 2021, which included a cleaning schedule, cleaning log, and recall protocol. After reviewing the inspectional findings and your response to the observations listed in the FDA 483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR part 117, Subpart C):
1. You did not prepare, or have prepared, and implement a food safety plan as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by your preventive controls qualified individual (PCQI) and must include the following:
(1) A written hazard analysis, as required by 21 CFR § 117.130(a)(2);
(2) Written preventive controls, as required by 21 CFR § 117.135(b);
(3) A written supply-chain program, as required by Subpart G;
(4) A written recall plan, as required by 21 CFR § 117.139(a);
(5) Written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
(6) Written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
(7) Written verification procedures, as required by 21 CFR § 117.165(b).
2. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically:
a. You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Your 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.
b. You 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 a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii). Your 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 a preventive control (see 21 CFR § 117.165(a)(3)).
c. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they are a hazard requiring a preventive control. Your facility manufactures soft flour and corn tortillas using wheat flour and corn flour. These ingredients have been associated with mycotoxins such as deoxynivalenol (DON) and aflatoxin, respectively.
3. You 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 your facility will not be adulterated under Section 402 of the Act or misbranded under Section 403(w) of the Act, as required by 21 CFR § 117.135(a)(1). 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 (see 21 CFR § 117.135). 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 (see 21 CFR § 117.140).
For example, food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens are included on the label and that food is protected against allergen cross-contact (see 21 CFR 117.135(c)(2)). You do not have controls in place to adequately control the hazard of allergen cross-contact as evidenced by the following. Production employees were observed using a metal can as a measuring cup to measure and dispense allergenic (whey) and non-allergenic ingredients during the production of both flour and corn tortillas with no cleaning of the can in-between. Additionally, on July 7, 2021, the metal can exhibited a caked-on reside from various dry ingredients from the flour tortilla production and was then used on the corn tortilla production line without cleaning prior to use. Further, you do not have controls in place to adequately control the hazard of undeclared allergens due to incorrect labeling, as evidenced by the following. Your facility manufactures soft flour tortillas that contain allergens such as wheat and whey (milk). Production employees were observed packaging tortillas but there was no evidence of checks that correctly labeled bags were used.
Your written FDA 483 response dated July 26, 2021, included copies of your facility’s recall procedure, cleaning schedule, and an in-use cleaning schedule log. However, you did not provide information as to how these documents apply to preparing and implementing a food safety plan. You did not include in your response information concerning developing a food safety plan to include evaluating whether hazards require a preventive control and written preventive controls. In the response, your PCQI stated that they would be sending a response to the FDA 483 observations in a later email. However, no additional response has been received.
This is a repeat observation from the July 30-31, 2019, FDA inspection, during which time you stated that you would conduct a hazard analysis and create a food safety plan.
Current Good Manufacturing Practice (21 CFR part 117, Subpart B):
4. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, FDA investigators observed the following:
a. Water was dripping from a ceiling with peeling paint onto a pallet of (b)(4)-(b)(4) bags of flour.
b. 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.
5. You did not ensure that your cleaning compounds and sanitizing agents are safe and adequate under the conditions of use, as required by 21 CFR § 117.35(b)(1). Specifically, during the inspection, FDA investigators observed the following:
a. Employees were not monitoring sanitizer solutions and were using (b)(4) sanitizer at a concentration of less than the manufacturer’s recommendation (b)(4) on a food contact surface. Specifically, when an FDA investigator tested with test strips (b)(4) solutions that were intended to sanitize the (b)(4) mixer, the concentration was found below 10 ppm and 100 ppm for the two solutions.
b. Employees did not allow the sanitizers to adequately air-dry after being sprayed onto food-contact surfaces, as directed by the manufacturer’s directions. Your PCQI explained that you do not allow the sanitizer to air dry, instead your firm wipes off the sanitizer after it has been applied.
6. You did not identify sanitizing agents in a manner that protects against contamination, as required by 21 CFR § 117.35(b)(2). Specifically, unlabeled containers/bottles containing unknown substances were observed being used on the tortilla oven conveyor belts, which are food-contact surfaces. According to your PCQI, some containers/bottles contained non-stick agents, and others contained sanitizer solutions.
7. You did not take effective measure to exclude pests from your food plant to protect against contamination of food, as required by 21 CFR § 117.35(c). Specifically, on July 7, 2021, FDA investigators observed the following:
a. Several live insects were crawling and flying inside the production room.
b. 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.
c. An unscreened door was open at the north side of the facility during the production of soft flour and corn tortillas.
d. There were gaps along two screened doors located in your facility’s loading areas on the northeast side and west side of the building.
8. You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food, as required by 21 CFR § 117.80(c)(2). Specifically, during the inspection, FDA investigators observed:
a. 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.
b. 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.
Your written FDA 483 response did not specifically address these FDA 483 observations; therefore, we are unable to evaluate whether you have corrected these deviations.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing the recurrence of occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice, including seizure and injunction or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to address violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Section 743 of the FDCA (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection, assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.
Your written response should be sent to Rene R. Ramirez, Compliance Officer, U.S. Food and Drug Administration, 1201 North Main Street, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Ramirez at email@example.com or (210) 308-1425.
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
Texas Department of State Health Services
Lori Woznicki, M.P.H.
Food and Drug Inspections Branch Manager
1100 West 49th Street
Austin, TX 78756