Inspections, Compliance, Enforcement, and Criminal Investigations
Flathead Fish and Seafood Company 27-Sep-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Seattle District |
22201 23rd Drive SE
Bothell, WA 98021-4421
September 27, 2005
RETURN RECEIPT REOUESTED
In reply refer to Warning Letter SEA 05-34
Richard A. Adams, President
Flathead Fish and Seafood Company
264 Twins Lake Road
Whitefish, MT 59937
Dear Mr. Adams:
We inspected your seafood processing facility, located at 264 Twins Lake Road, Whitefish, Montana on June 3 & 7, 2005. 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, 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 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). Accordingly, your refrigerated canned Dungeness crabmeat and pasteurized blue crabmeat, cooked shrimp meat in plastic tubs with snap-on-lids, refrigerated vacuum-packaged hot smoked salmon, and refrigerated Scombroid species 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 Guidance through links in FDA's home page at www.fda.gov.
Your significant violations 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 reasonably likely to occur, to comply with 21 CFR 123 .6(a) and (b). However, your firm does not have a HACCP plan for refrigerated cooked canned Dungeness crabmeat, refrigerated pasteurized blue crabmeat, and cooked shrimp meat in plastic tubs with snap-on lids to control the food safety hazard of pathogens.
2. You must have a HACCP plan that at a minimum lists the critical limits that must be met to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR 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 for Fresh Smoked Salmon (refrigerated vacuum-packaged hot smoked salmon) lists a critical limit at the receiving critical control point that is not adequate to control Clostridium botulinum. You must include a critical limit that ensures that 3.5% water phase salt has been achieved, in order to control Clostridium botulinum in the finished product.
Also, since the hot smoked salmon is a ready-to-eat product, we recommend including a maximum receiving temperature critical limit at the receiving critical control point of not more than 40°F.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4) . However, your firm's HACCP plan for refrigerated vacuum-packaged hot smoked salmon lists a monitoring procedure of visually checking for gel packs three times a week at the storage critical control point that is not adequate to control the hazard of Clostridium botulinum, in that it fails to achieve monitoring of your listed critical limit of 40°F. Specifically, monitoring the presence of gel packs provides no information associated with actual temperatures. Moreover, monitoring only three times per week provides no assurance that temperatures or gel packs were properly maintained between the monitoring intervals. You should implement monitoring procedures that provide continuous monitoring for temperature of the cooler during storage with a visual check once per day. For more information, see the Fish & Fisheries Hazards & Controls Guidance, 3rd Edition, Chapter 12:Pathogen - Growth.
4. Because you chose to include corrective action plans in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for Scombroid species at the receiving critical control point to control Scombrotoxin (Histamine) formation; and your corrective action plan for your fresh smoked salmon at the receiving critical control point to control pathogens are not appropriate. Your corrective action plans for these products list °find and evaluate" which do not include what you will do with the affected product if you deviate from your critical limits.
5 You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for three of the eight areas of sanitation required for the processing of your ready-to-eat products including your refrigerated crabmeat, shrimp and vacuum-packaged hot smoked salmon.
These three areas are:
a. Safety of water
b. Prevention of cross-contamination
c. Labeling, storage, and use of toxic compounds
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.
Please send your reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issues in this letter, please contact CO Donovan at (425) 483-4906.
Charles M. Breen