- Lopez Tortilla Foods Inc.
- Issuing Office:
- Dallas District Office
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Office of Human and Animal Food Operations West Division 3
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204
June 14, 2017
UPS OVERNIGHT MAIL
Armando J. Lopez, Owner
Lopez Tortilla Foods, Inc.
9727 Brockbank Drive
Dallas, Texas 75220
Dear Mr. Lopez:
Between the dates of January 24, 2017 to January 27, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 9727 Brockbank Drive, Dallas, Texas 75220, where you manufacture human and animal food products. The inspection revealed serious violations of the regulations of 21 Code of Federal Regulations (CFR) Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. Accordingly, we have determined that your products are 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 has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You can find the Act and the 21 CFR through the link in FDA’s home page at http://www.fda.gov. The FDA has not received a written response from your firm concerning the FDA 483, Inspectional Observations, which was issued to your firm at the conclusion of your inspection on January 27, 2017.
During our inspection, we observed the following significant violations:
1. Your firm failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, rodent excreta pellets were observed on top of final product packaging of three (3) finished products in your distribution warehouse. Also, a cat was observed entering a storage area used to house ingredients. Four (4) of the roll up bay doors in your receiving and distribution area were found to be in disrepair with holes ranging from approximately 1 to 8 inches. A similar observation was also brought to your firm's attention at the close out of inspections in 2014, 2009 and 2011.
2. You failed to store finished food under conditions that will protect the food against physical, chemical, and microbial contamination, as well as, against deterioration of the food and the container, as required by 21 CFR 110.35(c). Specifically, numerous loose rodent bait pellets were found along the South, East and West walls of your receiving and distribution warehouse. These pellets were found directly under palletized, ready to eat, finished products. This issue is also noted on your pest control records supplied to you from your pest control official on December 16, 2016; December 22, 2016 and January 13, 2017.
3. Your firm failed to clean food-contact surfaces of equipment as frequently as necessary to protect against contamination, as required by 21 CFR 110.35(d)(3). Specifically, the rounder divider for tortilla dough located in the southwest corner of the production floor was soiled with dark rings throughout the surface of the conveyor. A similar observation was also brought to your firm's attention at the close out of the inspections in both 2014 and 2011.
4. Your firm failed to clean and sanitize utensils and equipment in a manner that protects against contamination of food, food contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(a). Specifically, the main hose used to transport water to the cooking kettles throughout the cooking process was observed on the production area floor. Also, the silo corn connector hose used for incoming corn was lying on the ground in the parking lot. A similar observation was also brought to your firm's attention at the close out of the inspections in both 2014 and 2011.
5. You failed to adequately drain areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests, as required by 21 CFR 110.20(b)(4). Specifically, your firm had standing water underneath the corn cooking system in the cooking and steeping room. The unevenness, pitting and inadequate draining of the water can provide harborage for pathogenic organisms. A similar observation was also brought to your firm's attention at the close out of the inspections in both 2014 and 2011.
6. Your firm failed to properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 110.2o(a)(1). Specifically, your firm has broken wood pallets and loose plastic trash piled approximately six (6) feet away from the damaged doors leading to the receiving and distribution warehouse. Also, there was a dumpster overflowing with garbage and waste scrap metal along the south wall of the receiving and distribution warehouse. This issue is also noted on your pest control records supplied to you from your pest control official from September 02, 2016 through January 13, 2017. A similar observation was also brought to your firm 's attention at the close out of the inspections in both 2014 and 2011.
7. Your firm failed to provide sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations, as required by 21 CFR 110.20(b)(1). Specifically, multiple pallets with finished product packaging were stored directly against the walls of the receiving and distribution warehouse in such a manner to impede proper inspection and cleaning by your employees and/or your pest control operator. Also, this issue was brought to your attention and recorded in the documents supplied to you by your pest control official on multiple occasions.
8. Your firm failed to require personnel to wash their hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically, it was observed on 01/ 24/2017, your firm's staff on production lines 1,2,3, and 4 were using bare hands to prepare packaging materials such as cardboard boxes and tape guns. These same employees were then observed using bare hands to handle ready to eat, finished product, tortillas and tortilla corn chips without first washing their hands. A similar observation was also brought to your firm's attention at the close out of inspections in 2011, 2013 and 2014
9. Also, your firm did not provide hand-washing facilities that are adequate and convenient and furnished with running water at a suitable temperature as required by 21 CFR 110.37(e). Specifically, directly behind four (4) production lines at the East area of the production room, the hand washing station failed to provide hot water. Also, this hand washing stations' soap dispenser was empty. A similar observation was also brought to your firm's attention at the close out of inspections in 2009, 2011, 2013 and 2014.1.
Listed above are violations found during the inspection on January 24, 2017 to January 27, 2017. Among this list are repeat violations that have been brought to the attention to your firm during previous inspections in 2014, 2013, 2011 and 2009 which you have failed to correct. All repeat violations are noted in the above list. The FDA has not received any response in writing identifying any corrective actions that have been taken.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment and the products that you manufacture are in compliance with all requirements of the Act and federal regulations. It is your responsibility to review all products that you manufacture and distribute commercially to determine if they are subject to the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR 110). You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
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 reinspection 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to S. Alexander Hamblin, Compliance Officer, U.S. Food and Drug Administration, Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact S. Alexander Hamblin at 214-253-5240.
W. Charles Becoat
Acting District Director
Office of Human and Animal Food, WD3
cc: Lori Woznicki, Food and Drug Inspections Branch Manager
Division of regulatory Services, Texas Department of State Health Services
1100 E. 49th Street- Mail Code 1987
Austin, Texas 78756