Inspections, Compliance, Enforcement, and Criminal Investigations
Pelican Packers, Inc. 8/20/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
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
P.O. Box 51
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 have a HACCP plan that, at a minimum, lists 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 reduced to an acceptable level the occurrence of the identified food safety hazard. However your firm's HACCP plan for "Albacore tuna in a can" lists critical limits at the "all processing before retorting" critical control point that are
not adequate to control histamine formation. Your critical limits listed as "up to (b)(4)F for less than (b)(4) hrs" are not adequate to control and prevent time and temperature abuse that is reasonably likely to lead to excessive histamine development. Because histamine formation is cumulative and can occur at any interval when fish are exposed to unrefrigerated conditions, FDA recommends processors maintain histamine forming fish at 40°F or below during any extended time periods such as during holding, thawing and storing.
For example, our investigator observed several steps including thawing of your frozen fish and in-process storage of thawed fish where, in the absence of controls, time/temperature abuse would be expected to lead to excessive histamine development. Consequently, FDA suggests your firm include a "thawing" critical control point, conducted under refrigerated conditions in a cooler equipped with a continuous monitoring device capable of monitoring and recording the times and temperatures during the entire thaw cycle. Additionally, we suggest including a "storage" critical control point for storing the thawed fish that are held prior to retorting. Storage needs to be conducted under refrigerated conditions in a cooler equipped with a continuous monitoring device capable of monitoring and recording the times and temperatures during the entire thaw cycle.
We further suggest a daily check of the continuous monitoring record to ensure that temperatures were maintained at or below 40°F for the entire duration of the holding period, as well as a daily check of the monitoring equipment itself.
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 Ms. Elrand at (425) 483-4913.
Charles M. Breen
cc: WSDA, with disclosure statement