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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Villa Tatra, Inc. 9/29/11


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

Public Health Service
Food and Drug Administration
 Southwest Region
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
5th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100 

September 29, 2011



Mr. Maciej Feusnierz
Villa Tatra, Inc.
729 Pinewood Drive
Lyons, CO 80540

Ref.#: DEN-11-21-WL

Dear Mr. Kusnierz:

The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 729 Pinewood Drive, Lyons, Colorado, on August 22-30, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, (21 CFR 123).

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery 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 cold smoked fish and hot smoked fish are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as 11 "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for cold smoked salmon does not list the food safety hazard of Staphylococcus aureus at the brining step. The failure of the plan to list hazards that are reasonably likely to occur is also prima facie evidence that the hazard analysis was inadequate. (form FDA 483 item #4)

2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points (CCP), to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for cold smoked salmon does not list the critical control points of receiving and raw ingredient storage for controlling the food safety hazard of pathogen growth, and the critical control point of freezing for the control of parasites. (form FDA 483 item #1)

3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for hot smoked salmon lists a critical limit. of (b)(4) at the smoker baking critical control point that is not adequate to control Clostndium botulinum growth.

An internal temperature of 145 degrees for 30 minutes is required to control Clostridium botulinum growth. You do not take internal temperatures of salmon at the smoker CCP, and you have provided no evidence that smoking your salmon a (b)(4) minutes causes the internal temperature of the salmon to reach (b)(4) minutes. (form FDA 483 item #2)

4. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of observing and documenting that the temperature does not rise above 90 degrees F at smoker critical control point to control Clostridium botulinum listed in your HACCP plan for cold smoked salmon. (form FDA 483 item #7)

5. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control Clostridium botulinum hazard when your process for hot and cold smoked fish deviated from your critical limit at the storage critical control point. The temperature in your storage cooler exceeded (b)(4) degrees F for approximately (b)(4) hours during the week of June 12, 2011, without corrective action being taken by your firm. (form FDA 483 item #3)

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

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. You should include in your response documentation such as HACCP 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.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

For your information, we collected environmental swab samples for microbial analysis from 50 locations in your processing facility. These environmental swabs were identified with sub numbers in sample INV607028. We received the laboratory analyses on September 16, 2011. Environmental swab, #28, collected from the basin of the stainless steel sink used to rinse fish after brining, was found to contain Listeria innocua. Although Listeria innocua is not considered to be a pathogenic (disease causing) bacteria, it is considered to be an indicator of the possible presence of Listeria monocytogenes, which is pathogenic. The other sub samples were negative for Listeria species.

You should take prompt action to correct any insanitary conditions that may contribute to the presence of disease causing bacteria in your processing facility.

Please send your reply to: Food and Drug Administration, P.O. Box 25087, (6th Avenue and Kipling Street, DFC, Bldg 20), Denver, CO 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions regarding any issues in this letter, please contact Mr. Sherer at (303) 236-3051, or by email at william.sherer@fda.hhs.gov



Ann M. Adams
Acting District Director