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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Burr Favara 1/16/13


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

Public Health Service
Food and Drug Administration
 Kansas City District
Southwest Region
8050 Marshall Drive Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100


January 16, 2013
Ref. - KAN 2013-05
Mr. David E. Burr, Owner
Burr Favara Enterprises
4910 F Street
Suite 200
Omaha,NE 68117-1430
Dear: Mr. Burr:
We inspected your seafood processing facility, located at 4910 F Street Suite 200 Omaha, NE 68117-1430 from December 17-19, 2012.  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. 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).
Our inspection also found violations of FDA's Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (cGMP) regulation (21 CFR Part 110). These violations also cause the products manufactured in your facility to be adulterated within the meaning of Section 402(a)(4) of the Act in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.  You may find the Act, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance, and the CGMP regulation through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
Seafood HACCP violations
1.  You must conduct or have conducted for you a hazard analysis for each fish or fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur as required by 21 CFR 123.6(a) and (b).  However, your firm does not have a written HACCP plan for your ready to eat tuna products including the Tuna Salad Sandwich.
cGMP violation
1.  Your employees must wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) in an adequate hand washing facility after each absence from the work station and at any time their hands have become soiled or contaminated as required by 21 CFR 110.10(b)(3).  However, during our inspection your employee was observed to handle the walk in freezer door and a trash can then returned to making ready to eat products without washing or sanitizing their hands at any time during these operations.
We acknowledge receipt of your written response, dated January 2, 2013, to the FDA-483 issued at the close of the inspection on December 19, 2012.  We reviewed your response and found it inadequate in that you did not provide detail about the proposed corrective actions.  We will verify adequacy of these corrective actions during the next inspection.
We may take further action if you do not promptly correct these violations.  For instance, we may take further action to seize your product(s) 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.
Your response should be sent to Patrick L.Wisor,Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 11630 West 801 Street, Lenexa, Kansas 66214-3340.
John W. Thorsky
District Director
Kansas City District Office