| Public Health Service Food and Drug Administration |
New Orleans District
|
Department of Health and Human ServicesJuly 27, 2011
WARNING LETTER NO. 2011-NOL-19
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Berenice E. Lopez, President
La Villa Tortilleria, Inc.
1223 Columbia Avenue
Franklin, Tennessee 37064-3618
Dear Ms. Lopez:
On April 20 and 22, 2011, a U. S. Food and Drug Administration (FDA) investigator inspected your corn tortilla manufacturing facility, located at 1223 Columbia Avenue, Franklin, Tennessee. The inspection found significant violations of FDA’s Current Good Manufacturing Practice requirements for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause your corn tortilla products to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 342(a)(4)], because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. At the conclusion of the inspection, the FDA investigator issued a Form FDA 483, Inspectional Observations, to Rosa E. Lopez, Co-Owner and Secretary. You may find the Act and FDA’s regulations through links in FDA's Internet home page at www.fda.gov.
Your significant violations were as follows:
1. Your firm failed to take all reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging material conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. This includes washing hands thoroughly (and sanitizing, if necessary, to protect against contamination with undesirable microorganisms) 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, our investigator observed:
• Two employees, on eight separate occasions, handling raw tortilla dough and then handling finished tortillas, during processing operations, without first washing their hands;
• Three employees, on five separate occasions, picking up discarded tortillas from the floor and then handling finished ready-to-eat (RTE) tortillas without first washing their hands;
• One employee touching the front of his visibly soiled pants and then handling RTE tortillas without first washing his hands;
• One employee adjusting the control knob on the raw tortilla former and then packaging RTE tortillas without first washing his hands; and,
• Two employees, on three separate occasions, returning to the production room from your firm’s retail kitchen and resuming work, including handling RTE tortillas, without first washing their hands.
2. Your firm failed to maintain buildings, fixtures and other physical facilities in a sanitary condition to prevent food from being contaminated, and failed to conduct cleaning and sanitizing of equipment in a manner which protects against contamination of food and food-contact surfaces, as required by 21 CFR 110.35(a). Specifically, our investigator observed on April 20, 2011, after processing operations had ended, an electric leaf blower was used to clean the floor of the production room and the tortilla conveyors, by blowing off the remaining dried product from the conveyors. This blew debris from the floor and the conveyors into the air around processing equipment.
3. Your firm failed to properly maintain plant equipment and to use equipment so as to preclude the adulteration of food with any contaminants, as required by, 21 CFR 110.40(a). Specifically, our investigator observed:
• The guide used to control the fall of tortillas as they exited the oven conveyor onto the cooling conveyor was made of a plastic material which was torn and visibly stained.
• Paper towels were used in place of rubber gasket material in multiple components of the tortilla forming machine and in direct contact with raw tortilla dough during processing operations. Furthermore, prior to placement in the tortilla forming machine, the paper towels were dipped in a sanitizing solution observed to have a chlorine concentration above 200 ppm, which could cause the residue to become a food contaminant.
4. Your firm failed to use sanitizing agents on food-contact surfaces under safe conditions of use, as required by 21 CFR 110.35(d)(5). Specifically, on April 20, 2011, our investigator observed on three occasions your employees diluted chlorinated bleach with water without measuring the amount of each component used and without testing the chlorine concentration levels of the sanitizing agent before use. This diluted chlorinated bleach was used on the tortilla dough table and tortilla former components, which contact the raw tortilla dough, and was used to wipe down the stacking and packing tables, which contact RTE tortillas prior to packaging. Our investigator observed the diluted chlorinated bleach had a chlorine concentration above 200 ppm on all three occasions, which could cause the residue to become a food contaminant.
5. Your firm failed to provide adequate screening or otherwise protect against pests, as required by 21 CFR 110.20(b)(7). Specifically, our investigator observed the bottom of the screen on the back door of the production room was torn. This door opens to the outside of the firm.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with the Act and its implementing regulations. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including, but not limited to, seizure and/or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the noted violations and to prevent recurrence. Your response should include any documentation necessary to show correction has been achieved. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the U.S. Food and Drug Administration, Attention: Cynthia R. Gibson, Compliance Officer, at the above address. If you have questions regarding any issues in this letter, please contact Ms. Gibson at (251) 344-8208, extension 105.
Sincerely,
/s/
Monica Maxwell
Acting District Director
New Orleans District
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