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
March 20, 2014
Ref: DEN-14-05 WL
VIA UPS Overnight Mail
Mr. Ray A. Francisco
Facility Team Leader
Whole Foods Market Denver Distribution Center
17900 East 32nd Avenue
Aurora, Colorado 80011-1569
Dear Mr. Francisco:
We inspected your Denver Distribution Center, located at 17900 East 32nd Avenue, Aurora, Colorado, on January 14-24, 2014. We found that you have violations of the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 [21 CFR 123 & 110]. 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 21 CFR 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). Your firm is a warehouse, which is a "processor" within the meaning of the Seafood HACCP Regulations, 21 CFR 123.3(I). 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 tuna, sardines, anchovy, mackerel, bluefish, mahi-mahi, and wahoo 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 Guidancethrough links in FDA’s home page at www.fda.gov.
Your significant violation is as follows:
You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you process 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 reasonable likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for scombroid/histamine forming species fish such as tuna, sardines, anchovy, mackerel, bluefish, mahi-mahi, and wahoo to control the food safety hazard of histamine.
We received your written response on February 7, 2014. We have reviewed your response and find that without the HACCP plan for your scombroid/histamine forming fish and supporting documentation, it is inadequate to allow us to evaluate all your corrections to the violations.
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 plans, monitoring 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.
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) 236-3024.