| Public Health Service Food and Drug Administration |
Seattle District |
Department of Health and Human Services
December 7, 2010
VIA UPS
In reply refer to Warning Letter SEA 11-03
Mr. Scott Blake
President/Co-Owner
Copper River Seafoods, Inc.
4000 W. 50th Ste #2
Anchorage, AK 99502
WARNING LETTER
Dear Mr. Blake:
We inspected your food and seafood processing facility located at 300 Cannery Row, Cordova, Alaska, on August 3 and 4, 2010. We found that you have serious violations of the Low Acid Canned Food (LACF) regulation, Title 21, CFR, Parts 108 and 113, the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123, and the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, CFR, Part 110, (21 CFR 108, 113, 123 and 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 smoked salmon and other seafood products 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 CGMP regulation, the LACF regulation, 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 monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b).
However, your firm did not monitor condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, proper use, labeling and storage of toxic chemicals, and protection of food from adulteration from condensate, cleaning/sanitizing agents, or other chemical, physical, and biological contaminants as evidenced by:
a. Residual food and dirt on utensils, equipment and exposed surfaces in food preparation areas as follows:
i. On the underside of the shelf directly above the exposed containers of smoked salmon chunks in the jar filling room.
ii. On the handle and outside and inside surfaces of the door of the drying room where strips of salmon were being dried.
iii. On the inner surfaces of the lifter base plate and seamer head chuck and rolls of the double seam machine in the smoking room.
iv. On handles and surfaces of the plastic baskets used for holding jar cover rings. The baskets are also used for holding and transporting rinsed jars of smoked salmon prior and after processing.
v. Inside the sanitizer dispenser in the Ikura room.
vi. Inside the folded plastic guide of the glaze-up machine used for individually frozen fish.
vii. On the sides of the rollers and frames of the fresh and frozen packing table.
viii. On the teeth of the belt of the filleting machine.
b. Dripping condensation from overhead piping above product storage and processing areas. Multiple sections of this piping were observed to be coated with dirt and fish residue which could be carried by the drips to the food below.
c. Peeling paint above product handling areas, specifically on the ceiling of the hallway in the fresh and frozen fish packing area where racks of fish are moved on their way to the blast freezer in the fillet room.
d. Improper chemical storage next to exposed product, specifically two bottles of chemicals marked “sanitizer” and “alcohol” were stored hanging from a storage shelf directly above containers of exposed smoked salmon chunks staged for jar filling. Also, a container of chemical was stored on the same shelf where a container of exposed jar lids were stored.
e. Incoming fish dropped on the bird-soiled wooden floor of the receiving dock were placed back into the production totes without sanitizing or discarding.
f. The de-watering box is in an open shed exposed to the elements and possible bird contamination.
2. You must file a thermal process for a low-acid canned food with the FDA prior to packing a new product to comply with 21 CFR 108.35(c)(2). Your firm failed to file a process for your smoked salmon in foil pouches for which you have been processing since 2003 (as evidenced by a processing schedule dated June 1, 2003 by (b)(4) process authority) or when changes were made to that process (as evidenced by an updated processing schedule dated May 17, 2010 also by (b)(4). Additionally, you did not notify FDA of changes to your LACF registration contact information (firm name and mailing address change).
3. Whenever critical factors for any process are out of control for any low-acid food or container system as disclosed from records by processor check or otherwise, you must either fully reprocess that portion of the production involved, keeping full records of the reprocessing conditions or, alternatively, must set aside that portion of the product involved for further evaluation as to any potential public health significance by a competent processing authority, to comply with 21 CFR 113.89. However, you failed to fully reprocess those portions of production involved or set aside the product involved for further evaluation as to any potential public health significance by a competent processing authority, when you failed to control or satisfy the minimum requirements of the critical factor of the product fill weight outlined in the scheduled process. Specifically, your scheduled process for ½ lb cans of smoked salmon specifies the fill weight is not to exceed (b)(4) ounces; however, on June 3 and 10, 2010, you deviated from your scheduled process by processing smoked salmon in ½ lb cans that contained (b)(4) ounces each. These products were not reprocessed or set aside for further evaluation as to any potential public health significance by a competent processing authority.
4. You must conduct 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 123.6(a) and (b). However, your firm does not have a HACCP plan for smoked salmon strips (destined for LACF processing) to control the food safety hazards of Staphylococcus aureus toxin formation during the drying step.
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 an LACF scheduled process, a HACCP plan, 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 LACF regulation (21 CFR Part 113), 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 written reply to the Food and Drug Administration, Attention: Heidi Marks, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Ms. Marks at (425) 483-4862.
Sincerely,
/s/
Charles M. Breen
District Director
Enclosure:
Copy of FDA 483
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