Inspections, Compliance, Enforcement, and Criminal Investigations
Da'Vita Foods Company, Inc. 8/16/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Baltimore District Office|
August 16, 2013
Return Receipt Requested
Walter Alonso, Vice President and General Manager
Da’Vita Foods Company, Inc.
21726 Academy Terrace
Hagerstown, MD 21740
Dear Mr. Alonso:
We inspected your firm, a bakery, located at 21726 Academy Terrace, Hagerstown, MD 21740, on July 15-17, and 24, 2013. We found that you have serious violations of the good manufacturing practices (GMPs), Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). In accordance with 21 CFR 110, failure of a bakery to operate in accordance with the requirements of Part 110, renders bakery products 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). Accordingly, your bakery products are adulterated, as they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. You may find the Act and the GMP regulations through links in FDA's home page at www.fda.gov.
Specifically, our inspection of your facility revealed the following GMP violations:
1.) You must take proper precautions to protect food from contamination with extraneous material; properly store equipment, and remove litter and waste that may constitute an attractant or harborage area for pests within the immediate vicinity of the plant buildings or structures; operate air-blowing equipment in a manner that minimizes the potential for contaminating food, as required by 21 CFR 110.20 (b)(2) (a)(1) and (b)(6), respectively. Specifically, the following facility conditions were observed to be inadequate:
- There is no physical separation between the rice tortilla mixer and the uncovered sprouted wheat conveyor, which moves sprouted wheat to the grinder. Both of these machines are in Mixing Area 1. The rice tortillas are labeled as “WHEAT FREE” and “GLUTEN FREE”. Please provide clarification of your statement regarding final structural design and why it will take 10-12 months to complete.
- Trailers, old equipment, wood and debris were stored behind the North wall of the plant. Your response appears to be adequate.
- The air curtain with a buildup of dust of the coarse screen and interior was blowing unfiltered air directly onto exposed bread. Please clarify your statement regarding the installation of a Mechanical Depanner, and why this corrects the observation. The remainder of the response appears to be adequate.
2.) You must clean frequently as necessary to protect against contamination of food; take effective measures to exclude pests from processing areas; maintain buildings, fixtures, and physical facilities in repair to prevent food from becoming adulterated; store cleaned and sanitized portable equipment in a manner which protects food-contact surfaces from contamination, as required by 21 CFR 110.35 (a), (c), (d), (e). Specifically, the following conditions were observed:
- Residue of the previous day’s wheat product on the food contact surface inside the hopper of the handtmann tortilla extruder in the Tortilla Make-Up Room. This residue was observed just prior to manufacturing rice tortillas. Your response appears to be adequate.
- Eight flies on the floor on and around the floor drain behind the bread mixer in Mixing Area 2. Your response appears to be adequate.
- Paint peeling and flaking from the ceiling directly above exposed bread dough being conveyed from the chunker to the divider; and from the divider to the former in the Bread Make-Up Room. The proposed corrective action does not appear to correct the observation. Installation of tile on walls covered with apparent mold and mildew does not correct the observation. All other parts of your response appear to be adequate.
- Uncovered cleaned and sanitized meat tubs stored in the Cooler under the rusty ceiling with flaking paint. Your response appears to be adequate.
3.) You must adequately install and maintain plumbing to properly convey sewage and liquid disposable waste from the plant as required by 21 CFR 110.37(b)(2). Specifically, a paper towel was stuffed into an open joint of a PVC “T” fitting on the drain line in the Wrapping Area from the water fountain in the Oven Room. Your response appears to be adequate.
4.) You must take effective measures to protect against the inclusion of metal in food; construct and maintain equipment, containers and utensils used to convey food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(8) and (b)(7). Specifically, the following was observed:
- The reject arm on the tortilla line was not reset before an employee passed the (b)(4)mm ferrous, (b)(4)mm non-ferrous, and (b)(4)mm stainless steel test rods through (b)(4) times each, completing the startup testing. Your response appears to be adequate.
- Frayed and worn food contact surface of the conveyor belt on the bread dough former in the Bread Make-Up Room. Please provide clarification of your statement regarding ordering a new seal for Mixer #20, and why it will take (b)(4) weeks to be replaced.
5.) You must have smoothly bonded or well-maintained seams on food contact surfaces to minimize accumulation of food particles and organic matter and the opportunity for growth of microorganisms, as required by 21 CFR 110.40(b). Specifically, the following conditions were observed:
- Rough welds inside the manifold reducer on the hantmann tortilla extruding machine. Your response appears to be adequate.
- Welding spatter on the stainless steel table used to hand count tortillas in the Tortilla Wrapping Area. Your response appears to be adequate.
6.) You must wear beard covers where appropriate; refrain from drinking and storing beverages where food is exposed; and maintain adequate personal cleanliness, as required by 21 CFR 110 (b)(6), (b)(8), and (b)(2). Specifically, the following conditions were observed:
- An employee with facial hair de-panning exposed loaves of bread. The employee was not wearing a beard cover. Your response appears to be adequate.
- An employee walked from the bread packaging area to the tortilla packaging area while drinking from a can of Coca Cola. Your response appears to be adequate.
- Two employees wearing hairnets, aprons, and single service disposable gloves outside the rear of the building and return to the manufacturing area without changing them. Your response appears to be adequate.
Your response, dated August 1, 2013, was reviewed by the Compliance Branch within the Baltimore District Office. Based on the repetitive history of your firm and inspectional findings by FDA and Maryland Department of Health and Mental Hygiene (MDHMH), this Warning Letter was issued to you. Corrections made will be verified during a re-inspection of your facility.
We may take further action if violations are not corrected. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act and GMP regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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-1(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 respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations, as well as the remaining issues cited on the FDA-483, Inspectional Observations, issued to you on July 24, 2013. You should include in your response documentation such as a HACCP plan and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Evelyn Bonnin, Baltimore District Director, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Randy Pack at 410-779-5417 or firstname.lastname@example.org.
Baltimore District Office