Inspections, Compliance, Enforcement, and Criminal Investigations
Sam Uk Fish Cake Company 12-Jul-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
July 12, 2001
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 01-66Chul Lee, Owner
Sam Uk Fish Cake Company
1112 South 344 Street #304
Federal Way, Washington 98003
Dear Mr. Lee:
We inspected your firm located at 1112 South 344th Street, #304, Federal Way, Washington, on April 11,16, and 18, 2001, and found that you have serious deviations horn Title 21 of the Code of Federal Regulations (21 CFR) Part 123- Fish and Fishery Products (Seafood HACCP regulations). A FDA 483 form (copy enclosed) listing the deviations was presented to you at the conclusion of the inspection. These deviations, some of which were previously brought to your attention, cause your vacuum-packaged fried fish cakes to be in violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find this Act and the Seafood HACCP regulations through links in FDA?s homepage at www.fda.gov.
The deviations were as follows:
1. You must have a HACCP plan that lists the critical control points, to comply with 21 CFR 123.6(c)(2). Your firm?s HACCP plan for vacuum-packaged fried fish cakes does not list the critical control point of labeling to control the food safety hazard of allergens. This product contains wheat, soy, and egg products, which are allergens.
2. You must have a HACCP plan that lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). Your firm?s HACCP plan for vacuum-packaged fried fish cakes, which is distributed at ambient temperatures, lists critical limits at the pasteurization critical control point that are not adequate to control the food safety hazard of Clostridium botulinum. Our investigator reported that core temperatures of your packages exiting the pasteurizer reach [redacted] degrees F, but he could not determine the amount of time the product is cooked at this temperature. The Food and Drug Administration (FDA) recommends that a nonproteolytic cook for refrigerated products be 194?F for 10 minutes, 185 degrees F for 15 minutes, or a process that is equivalent.
The purpose of pasteurization is either: 1) to make the product safe for an extended shelflife, which involves eliminating the spores of Clostridium botulinum type E and nonproteolytic B and F; or 2) for eliminating or reducing the number of other target pathogens. Selection of that target organism is the critical factor that should be considered for your process.
If you choose to use a process other than that recommended by the FDA, you must verify that it is adequate to prevent the growth of Clostridium botulinum and its toxin formation. This verification should be done by your firm or under a process authority that can document and substantiate your process.
3. You must implement the record keeping system listed in your HACCP plan that includes the actual values and observations, to comply with 21 CFR 123.6(c)(7). On April 16, 2001, our investigator observed an employee working at the pasteurizer who did not record the value of time, temperature, and internal temperature at the time the observation was made.
4. Since you chose to include corrective actions in your HACCP plan your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). Your corrective action plan for vacuum-packaged fried fish cakes fails to identify & what you will do with the affected product and how you will prevent the deviation from recurring.
5. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). Your fm did not monitor proper labeling, storage, and use of toxic compounds.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations, and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations. 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 fm from operating.
Please respond in writing within three (3) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response documentation such as your revised HACCP plan and copies of your monitoring records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23d Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Lisa Elrand at (425) 483-4913.
Charles M. Breen
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