Inspections, Compliance, Enforcement, and Criminal Investigations
Okami, Incorporated, 10/16/09
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
6thAvenue & Kipling Street
Denver, Colorado 80225-0087
October 16, 2009
Ref: DEN-10-01 WL
RETURN RECEIPT REQUESTED
Ms. Laura L. McKee, Owner/President
11019 Penrose Street
Sun Valley, California 91352
Dear Ms. McKee:
We inspected your firm, Okami, Inc., located at 6211 East 42nd Avenue, Denver, Colorado on July 6-8, 10, 2009. Our inspection found that your firm has serious deviations from the Seafood Hazard Analysis 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). Accordingly, your vacuum packaged imitation pasteurized crabmeat is adulterated, in that it has 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 FDA's Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition, June 2001 (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:
1. You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR Part 123.6(a) and (b). However, your firm does not have a HACCP plan for cooked, refrigerated, vacuum packaged ready-to eat imitation crabmeat to control the hazard of pathogen growth and potential toxin formation, including Clostridium botulinum growth and toxin formation. Please be advised that in accordance with 21 CFR Part 123.6(b)(2) a HACCP plan is necessary for each kind of fish and fishery product processed by the processor, with a grouping of fish and fishery products being appropriate only when the food safety hazards, critical control points, critical limits, etc. are identical. Consequently, your current HACCP plan for "Frozen ingredients, Shrimp for use in Shrimp Sushi Rolls", is not appropriate as a plan to cover your vacuum packaged refrigerated imitation crab meat product because the hazards and controls are not identical.
We acknowledge receipt of your response dated August 10, 2009 in which you address this issue with your assertion that the hazard of pathogen growth and potential toxin formation is not significant and may be controlled with a prerequisite program because the imitation crab meat that you receive has been pasteurized (i.e., cooked) by the previous processor. However, your response does not provide any data or information to substantiate that the pasteurization process applied to the imitation crab meat is adequate to control pathogen growth and potential toxin formation in the absence of adequate refrigeration. Without this data or information, refrigeration remains a significant hazard that can not be covered or controlled with a prerequisite program.
In addition, your firm states in its August 10th response that you have corrected all the sanitation deficiencies and have addressed the findings of Listeria monocytogenes. These corrections, as described in your response, will be verified during the next inspection of your firm.
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.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing 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 corrections. 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 deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with 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.
H. Thomas Warwick, Jr.
Denver District Director