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WARNING LETTER

Montes Tortilla Factory MARCS-CMS 541060 —


Delivery Method:
UPS OVERNIGHT MAIL
Reference #:
2018-DAL-WL-03
Product:
Food & Beverages

Recipient:
Recipient Name
Dahlia Rodriguez
Recipient Title
Owner
Montes Tortilla Factory

7536 North FM 88
Weslaco, TX 78599
United States

Issuing Office:
Division of Human and Animal Food Operations West III (HAFW3)

United States


Dear Ms. Rodriguez:

 

Between the dates of August 21, 2017 to August 22, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 7536 North FM 88, Weslaco, Texas, where you manufacture ready to eat human 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 they have been prepared, packed, or held under insanitary conditions whereby they 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 August 22, 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, on August 21, 2017, pest control sticky traps along the walls in your production area were filled with dead and decaying animals and insects. Also, dead insects and apparent rodent excrement were along the walls and on the counter, that is approximately four (4) feet from the packaging area. In addition, live insects and a live lizard were seen crawling in the production platform, on the ingredient packing under an ingredient refrigerator unit.    

 

Further, you failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, on August 21, 2017 all doors and dock doors, except the front entry door, were open with no screens or way to exclude pests. Gaps in screens and door closures were seen once the doors were closed.

 

  1. Your firm failed to provide sufficient space for storage of materials as necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1). Specifically, racks along the East wall were filled with personal and firm items. There is no space in this rack area to look around the items or look at the wall and floor to inspect for pests. Ingredient storage is approximately five (5) feet from these storage racks along the East wall. This Rack along the east wall is potential harborage area for pests.     

 

  1. Employees at your firm failed to remove hand jewelry that cannot be sanitized during periods where food is being manipulated by hand, as required by 21 CFR 110.10(b)(4). Specifically, employees were packing finished, ready to eat tortillas while wearing wedding rings that were more than a plain band as well as nail polish on their fingernails.

 

Also, you failed to exclude employees consuming food and beverages in areas where food is exposed, as required by 21 CFR 110.10(b)(8). Specifically, multiple personal beverages were found throughout the production as well as the packaging area. Also, multiple discarded food products were scattered throughout the production area; these items are not related to the product you manufacture.  

 

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 acidified foods regulations (21 CFR 114).  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 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 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.

 

 

Sincerely,

/S/

Edmundo Garcia, Jr.

District Director

Program Division 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 7875