111 Richman Street Black Hawk, CO80422 United States
Denver District Office
Department of Health and Human Services
Public Health Service Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
July 28, 2016
UPS via Overnight
Anthony M. Sanfilippo, Chief Executive Officer
3980 Howard Hughes Parkway
Las Vegas, NV 89169
Dear Mr. Sanfilippo:
The Colorado Department of Public Health and Environment (CDPHE) inspected your firm, Ameristar Casino Black Hawk, under contract with the Food and Drug Administration (FDA), located at 15173 State Highway 119, Black Hawk, Colorado on June 6, 2016. The inspection found that your firm has serious deviations from the seafood HazardAnalysis and Critical Control Points (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 CFR §123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the fishery products processed there 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). Your firm is a warehouse, which is a "processor" within the meaning of the Seafood HACCP Regulations, 21 CFR 123.3(l). See Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 60 Fed. Reg. 65;096 65, 114 (December 18, 1995); see also 21 CFR 123.3(k)(1) (defining "processing" to include the "storing" of fish or fishery products). Accordingly, your vacuum packed cold smoked salmon is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may be rendered injurious to health. You may find the Act, the Seafood HACCP Regulation, and FDA’s Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition, April 2011 (the Hazard Guide) through links in FDA’s home page at www.fda.gov.
The deviations that were found during the inspection were as follows:
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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (b). However, your firm does not have a HACCP plan for vacuum packed cold smoked salmon to control the food safety hazards of Clostridium botulinum toxin formation and growth of pathogens.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct these deviations. You should include in your response documentation such as your HACCP plans, copies of all related monitoring records and corrective actions, or other useful information that would assist us in evaluating your compliance. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your warehouse 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.
We may take further action if you do not promptly correct these violations. For instance, we may initiate regulatory action without further informal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.
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 reinspection-related costs. A reinspection 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. Reinspection-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 reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at 303-326-3024.