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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Chuck's Seafoods, Inc. 12/14/09


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

December 14, 2009


In reply refer to Warning Letter SEA 10-08

Jack G. Hampel, President
Chuck's Seafoods, Inc.
P.O. Box 5502
Charleston, Oregon 97420


Dear Mr. Hampel:

We inspected your seafood processing facility, located at 91135 Boat Basin Drive, Charleston, Oregon, on August 17 and 18, 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 canned Albacore tuna 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 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 lists monitoring procedures and their frequencies for each critical control point (CCP) to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plan for "Albacore Tuna" lists a monitoring procedure and frequency at the "Cooler Temp" CCP that is not adequate to control histamine formation. Specifically, your HACCP plan lists monitoring the cooler temperature each morning with a thermometer.

This one time temperature, conducted every 24 hours, is not adequate to ensure that products are not exposed to elevated temperatures for extended time periods due to fluctuations occurring between those checks.

FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, FDA recommends a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly. Alternatively, you may choose to perform a daily visual check of the adequacy of ice or cooling media surrounding product during refrigerated storage for those products that are stored on ice, such as your Albacore tuna; however, your HACCP plan and monitoring records should reflect this monitoring activity accordingly.

2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for "Albacore Tuna" at the "Cooler Temp" CCP to control histamine formation is not appropriate.

Specifically, your listed corrective action plan:

•  does not describe the steps to be taken to ensure that the cause of the deviation is corrected, and
•  can not be implemented because your firm monitors storage temperatures at a frequency of every 24 hours, consequently your firm has no means to determine whether the tuna has been exposed to a temperature over 40°F for over 4 hours. You have insufficient information available to take either course of action as described in your HACCP plan listed as "if exposure less than 4 hours product to be retorted or discarded".

3. 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 with sufficient frequency:

a. The proper labeling, storage and use of toxic chemicals [21 CFR 123.11 (b)(6)], as evidenced by two bottles containing cleaning compounds observed in the processing room without a label identifying the contents.
b. The maintenance of hand washing and toilet facilities [21 CFR 123.11 (b)(4)], as evidenced by the toilet in the women's bathroom which was not in good repair and would not flush.
c. The prevention of the cross contamination from insanitary objects to food and other food contact surfaces [21 CFR 123.11 (b)(3)], as evidenced by:

• An employee observed wearing earrings in the processing room (a repeat observation);
• Two employees observed hand packing tuna into cans without the presence of hair nets (a repeat observation); and
• Three processing aprons were observed stored on packing material in the storage room.

d. The protection of food, food packaging material, and food contact surfaces from adulteration [21 CFR 123.11 (b)(5)], as evidenced by:

• Two employees observed chewing gum in the processing room, and
• A cup containing coffee observed on the fillet table (where employees were filleting tuna).

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

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: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you
have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.



Charles M. Breen

District Director