Inspections, Compliance, Enforcement, and Criminal Investigations
Pelican Packers, Inc. 9/10/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
September 10, 2009
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-25
Lamar B. Edwards, President
Pelican Packers, Inc.
4152 Meridian Street, Suite 105
Bellingham, Washington 98226
Dear Mr. Edwards:
We inspected your seafood processing facility, located at 6069 Hannegan Road, Bellingham, Washington, on June 11-12, 16-17, 2009. 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, including the sanitation control procedures under 21 CFR 123.11, 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 albacore tuna in cans 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 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 implement the monitoring procedures and recordkeeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b), (c)(4) and (c )(7). However, your firm did not monitor and record the critical limits at the "All processing Before Retorting" critical control point as listed in your HACCP plan for "Albacore tuna in a can." Specifically, your HACCP plan stated that you will record time and temperature using a critical limit of "up to (b)(4)F for less than (b)(4)hrs" to control for Histamine formation. The firm was not monitoring or recording the time in which the thawing started on 6/11/09, so the length of time the fish was exposed to ambient temperature was unknown.
2. 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 safety of water with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110.
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 written reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421, If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4913.
Charles M. Breen
cc: WSDA, with disclosure statement