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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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La Hacienda Tortilleria Inc 9/11/09


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

New Orleans District
404 BNA Drive
Building 200, Suite 500
Nashville, TN 37217
Telephone: (615) 366·7801
FAX: (615) 366·7802

September 11, 2009



Carlos Yepez, President and Owner
La Hacienda Tortilleria, Inc.
2618 Grandview Avenue
Nashville, Tennessee 37211

Dear Mr. Yepez:

On June 24-25, 2009, U.S. Food and Drug Administration (FDA) investigators inspected your food manufacturing facility, located at 2618 Grandview Avenue, Nashville, Tennessee, The inspection was conducted to determine your compliance with FDA's Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Our investigators documented serious deviations from the regulations, which caused the tortilla products manufactured in your facility 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)), as the products were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. You may find the Act and associated regulations through links in FDA's Internet home page at http://www.fda.gov.

The deviations documented include the following:

1. You failed to ensure all personnel working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food [21 CFR 110.1O(b)). Specifically, you failed to ensure all personnel wash their hands thoroughly in an adequate hand-washing facility at any time when their hands may have become soiled or contaminated [21 CFR 110.10(b)(3)). Specifically, the following were observed during production operations:

• An employee who had been handling and packaging tortillas moved a wooden stand and then resumed handling and packaging the tortillas without washing his hands; and,

 • An employee who had been stacking tortillas picked up tortillas from the floor to throw them away and then resumed stacking tortillas without washing his hands.

2. You failed to take necessary precautions to protect against contamination of food, food contact surfaces, or food-packaging materials with microorganisms or foreign substances [21 CFR 110.10(b)(9)]. Specifically, the following were observed during production operations:

• One employee wore a hand brace that cannot be adequately cleaned or sanitized. The hand brace was uncovered and came into contact with tortillas during stacking operations; and,
• Corners and edges of plastic sheeting used to cover tortillas repeatedly came into contact with the floor while an employee placed the sheeting on top of the tortillas.

3. You failed to ensure all food-contact surfaces, including utensils and food-contact surfaces of equipment, were cleaned as frequently as necessary to protect against contamination of food [21 CFR 110.35(d)]. Specifically, plastic buckets used to scoop corn in the cooking tanks had dirt and ingredient build-up on their interior surfaces.

4. You failed to use all equipment and utensils in a way that precludes the adulteration of food with contaminants [21 CFR 110.40(a)]. Specifically, unmarked gray barrels were used to store food-contact surfaces (plastic sheeting) which were subsequently reused during production operations. Unmarked gray barrels were also used as trash receptacles and to store floor cleaning tools. Placing the sheets of plastic in unclean barrels and reusing the plastic sheeting during production could serve as a source of contamination.

5. You failed to exclude pests from your facility and to protect against the contamination of food by pests [21 CFR 110.20(b)(7), 110.35(c)]. Specifically:

• One live fly was present on top of tortillas while the tortillas were being stacked on racks;
• Live flies were present in the packaging area;
• Gaps, large enough to allow entry of pests, were present between the facility floor and walls, and the back and front doors leading to the outside; and,
• The back dock door leading to the outside was open during the inspection.

6. You failed to maintain buildings, fixtures, and other physical facilities of the plant in sanitary condition and sufficient repair to prevent food from becoming adulterated within the meaning of the Act [21 CFR 110.35(a)]. Specifically:

• The drop ceiling throughout the manufacturing area was dirty, peeling, and had missing and hanging tiles;
• Black plastic, which cannot be adequately cleaned, was used instead of or on top of some ceiling tiles;
• Peeling paint and dirt were present on the walls throughout the facility;
• Numerous holes were present in the walls throughout the facility; and,
• The wall behind the corn soak tanks was in disrepair, with sheets of wall material peeling off.

This letter is not intended to be a comprehensive list of deficiencies at your facility. It is your responsibility to ensure your facility operates in full compliance with the Act, the CGMP regulations, and all other applicable regulations.

You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure or injunction.

You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include in your response documentation, such as photographs, records, and other useful information, to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.

Please address your reply to Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding the contents of this letter, please contact Ms. Asente at (504) 219-8818, extension 104.



Patricia K. Schafer
Acting District Director
New Orleans District


Enclosure: Form FDA 483, dated June 25, 2009
cc: Rachel Gaines, Manager
La Hacienda Tortilleria, Inc.
2618 Grandview Avenue
Nashville, Tennessee 37211