- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameJose A. Hernandez
Recipient TitleGeneral Manager
- La Sonorense, Inc.
5403 S. Central Ave.
Phoenix, AZ 85040-3050
- Issuing Office:
- Division of Human and Animal Food Operations West IV
August 6, 2020
Ref: # DEN-20-06-WL
Dear Mr. Hernandez:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) corn and flour tortilla manufacturing facility located at 5403 S. Central Avenue, Phoenix, Arizona, from March 16, 2020 to March 21, 2020. During our inspection, 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), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117). At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations, listing the deviations found at your firm.
Based on FDA’s inspectional findings, we have determined the food manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that it was prepared, packed, or held under insanitary conditions whereby it 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 (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.
We received your response dated April 10, 2020, which included a summary of corrective actions taken and planned by your firm. After reviewing the inspectional findings and your response to the observations listed in FDA Form 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 (Subpart C):
1. You did not conduct a hazard analysis for any of your products to identify and evaluate known or reasonably foreseeable hazards for each type of food products manufactured or processed at your facility 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 undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control. Your facility receives, stores, and manufactures products that contain an allergen (wheat). Our investigator observed your 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 our inspection, your firm conducted a voluntary recall of your bulk Pressed Wheat Flour Tortillas that contain wheat flour as an ingredient due to undeclared wheat allergen on the product label.
b. You did not identify and evaluate bacterial pathogens (such as pathogenic E. coli, Salmonella, and Listeria monocytogenes) in your 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.
c. You did not identify and evaluate environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard after your (b)(4) step to determine whether the hazard requires a preventive control (see 21 CFR § 117.130(c)(1)(ii)). Your facility manufactures RTE food which is exposed to the environment after the (b)(4) 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.
d. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control. Your facility manufactures tortillas with wheat and corn flour. These ingredients have been associated with mycotoxins.
2. You did not identify and implement preventive controls for any of your products to provide assurance 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).
3. You did not prepare or have prepared and did not implement a written food safety plan for any of the products manufactured in your facility, as required by 21 CFR § 117.126(a)(1). A food safety plan must include the following:
a. The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
b. The written preventive controls, as required by 21 CFR § 117.135(b);
c. The written supply-chain program, as required by Subpart G;
d. The written recall plan, as required by 21 CFR § 117.139(a);
e. The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
f. The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
g. The written verification procedures, as required by 21 CFR § 117.165(b).
During the inspection, your assistant manager stated your firm would conduct a hazard analysis and create a food safety plan after construction of your new facility, but no timeline for the creation of the food safety plan or new plant construction was provided. Your written response did not provide any details to address the hazard analysis or food safety plan.
Current Good Manufacturing Practice (Subpart B):
1. You did not take effective measures to exclude pests from your manufacturing, processing and packing areas to protect against the contamination of food, as required by 21 CFR § 117.35(c). Specifically, our investigator observed:
a. The (b)(4) dock doors located on the east side of the facility remained open during each production day of the inspection, with employees, raw ingredients, and finished products passing in and out. The dock door is equipped with an (b)(4) which did not appear to be functioning properly during the inspection. There was also a 1 to 2-inch wide gap under and in-between the sliding dock doors. During the production of (b)(4)-inch wheat flour tortillas, an employee was seen placing proofed dough onto a dough feeder located approximately four feet from the open dock doors.
b. Apparent rodent excreta pellets were present on top of a large plastic bin containing a mixture of (b)(4) and (b)(4) which was used as an (b)(4) for boiling and soaking corn kernels.
c. Flying insects, too numerous to count, were in the production area and landing on the wheat flour dough feeder and ovens, including one insect directly on top of the prep table as employees were packaging flour tortillas.
Similar observations were made during the 2018 and 2019 inspections. In your written response, you stated you are in the process of replacing the back door to repair the gaps, and you will retrain employees to ensure that the (b)(4) are on at all times. We will evaluate the adequacy of your corrective actions during the next inspection.
2. Your equipment and utensils were not adequately maintained to protect against contamination, as required by 21 CFR § 117.40(a)(1). Specifically, on March 17, 2020, our investigator observed the plastic and metal portions of the belt on the feeder of the (b)(4) Tortilla oven and (b)(4) Tortilla oven were scarred and stained with apparent dark residue. A similar observation was made during the 2018 inspection. Your written response did not address this violation.
3. You did not clean and sanitize your utensils or equipment in a manner that protects against contamination, as required by 21 CFR § 117.35(a). Specifically, our investigator observed your sanitation process, which consisted of scraping to remove residual dough and wiping down the RTE tortilla processing areas using a cleaner/degreaser in (b)(4) water and a rag (b)(4), 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 (b)(4) conveyors used to transport the baked tortillas to packaging were not cleaned. Similar observations were made during the 2018 and 2019 inspections.
In your written response, you stated employees will be retrained on how to properly clean the metal vat where corn is cooked. Your response does not address the other referenced equipment or sanitation procedures and does not include photographs of cleaned equipment or other documentation to demonstrate that corrective actions have been completed and are effective.
4. You did not store and transport food under conditions that protect against allergen cross-contact, contamination of food, and deterioration of food, as required by 21 CFR § 117.93. Specifically, on March 17, 2020, our investigator observed several pallets of (b)(4)-lb. bags of raw materials, including wheat flour and corn flour, and boxes of finished RTE tortillas stored uncovered outside of the facility while employees carried out sanitation activities inside the production areas. Approximately 10 birds were on and around the raw ingredients while they were stored outside of the facility. After sanitation was completed, the materials were moved back inside the facility.
During the inspection, your assistant manager stated that finished products and raw materials were moved outside so employees would have more space to conduct sanitation activities. In your written response, you indicated you are unable to store raw ingredients inside the facility during production due to the size of the facility and that all ingredients are put away once production is complete. Your response did not provide an adequate corrective action plan to address this violation.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the 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 correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct these deviations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If your firm’s planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.
• You must establish and maintain records that document your employees received training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene as appropriate to the food, the facility and the individual’s assigned duties, as required by 21 CFR 117.4(d).
• All persons working in direct contact with food, food-contact surfaces, and food packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR § 117.10(b). During the inspection, our investigator observed a production employee walk inside the facility via the open dock door after getting a drink and resume cleaning the tortilla mixer without changing gloves or washing and sanitizing hands.
Section 743 of the Act (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 and 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. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs from the responsible party for the domestic facility.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Kathy Tormey, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Tormey at Kathleen.email@example.com or (303) 236-3137 if you have any questions about this matter.
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Foods –
Division IV West