Inspections, Compliance, Enforcement, and Criminal Investigations
San Simeon Incorporated 12/4/09
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
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
December 4, 2009
Ref: DEN-10-04 WL
RETURN RECEIPT REQUESTED
Mr. Kenneth H. Freberg, Owner
San Simeon Incorporated
2310 Yale Blvd SE, Suite A-5
Albuquerque, NM 87106
Dear Mr. Freberg:
We inspected your firm, San Simeon Incorporated, located at 2310 Yale Blvd SE, Suite A-5, Albuquerque, New Mexico on July 23-24, 2009. Our inspection found that your firm has serious deviations from the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, 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 21 CFR Part 123 renders the 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). Accordingly, your pasteurized cooked crabmeat and scombroid (histamine) producing finfish are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP Regulations 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 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 reasonable likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for pasteurized cooked crabmeat to control the hazard of pathogen growth and potential toxin formation, including Clostridium botulinum growth and toxin formation.
2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points, to comply with 21 CFR Part 123.6(c)(3). A critical limit is defined in 21 CFR Part 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 lists inadequate critical limits at the Storage critical control point in your "Raw finfish, histamine producing Amberjack, Bluefish, Escolar, Herring, Mahi, Mackerel, Shad, tuna (all species)" HACCP plan to control histamine growth/scombrotoxin formation. Your plan lists "Continual temp control or storage on ice" at this critical control point, however' there is no temperature parameter or limit associated with the reference to temperature control; and our investigation revealed that your histamine forming fish are not stored on ice.
Specifically, FDA recommends that storage temperatures be maintained at or below 40°F to control histamine formation. In addition, we recommend the use of temperature monitoring equipment on the cooler capable of continuously monitoring and recording the storage temperatures on a 24 hour a day/7 day a week basis, with a daily check of the record and the equipment.
3. Because you chose to include corrective action plans in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your raw histamine producing fin fish at the receiving and storage critical control points are not adequate to control histamine formation. Specifically, listing that you will "cool" and inspect or dispose is not adequate because cooling affected product (i.e., product that has already been temperature abused) will not prevent distribution of potentially adulterated fish into the marketplace. Histamine formation is cumulative and will occur during any extended time periods when the fish are exposed to temperatures above 40° F. Consequently, cooling temperature abused products is not recommended.
We may take further action if you do not promptly correct this violation. For instance, we may initiate regulatory action without further 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 plan, copies of all temperature 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 of the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP Regulations, and the Good Manufacturing Practice regulations (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.
Harry T. Warwick, Jr.
Denver District Director