| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human ServicesWARNING LETTER
VIA UPS
November 3,2010
Our Reference # 1000161240
Scott Bradshaw, President/Owner
Fish Brothers, Inc.
203 Taylor Way
Blue Lake, CA 95525
Dear Mr. Bradshaw:
We inspected your seafood processing establishment, located at 203 Taylor Way, Blue Lake, CA on August 10, 11, 12 & 13, 2010. 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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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 refrigerated vacuum packaged hot-smoked seafood products, such as hot-smoked vacuum packed Chum Salmon and hot-smoked vacuum packed Albacore Tuna, 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.) Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your HACCP plan for “Hot Smoked VACUUM PACKED FISH-except Tuna and Jerky” at each critical control point to control pathogen growth and/or C. botulinum toxin formation, and your corrective action plans for your HACCP plan “Hot smoked vacuum packed Tuna” at each critical control point to control histamine formation, pathogen growth and/or C. botulinum toxin formation are not appropriate because they do not resolve how the cause of the deviations will be corrected.
We acknowledge your response which indicates that you have included the following revisions to your HACCP plan for “Hot Smoked VACUUM PACKED FISH-except Tuna and Jerky”:
COOKING CCP: “ (b)(4) ”
We note that the cooking process involves both time and temperature parameters. The internal temperature must be held for a specific period of time. The corrective action does not address time.
Your response also indicates that you have included the following revisions to your HACCP plan for “Hot smoked vacuum packed Tuna”:
THAWING CCP: “ (b)(4) ”
We note that for thawing tuna, taking surface temperatures of a small sample is not considered an adequate corrective action to assure the safety of products exposed to unsafe holding and processing conditions. Depending on how your fish are thawed (e.g. in water or tempered) and batch size, the corrective action and monitoring procedure at this step should address how the time critical limit in the plan will be met.
BRINING CCP: “ (b)(4) ”
We note that under brining conditions, monitoring surface temperatures is not an adequate method of control for a corrective action plan. You should evaluate cumulative temperature exposures, and if fish have been exposed to times and temperatures above the critical limits, fish should either be tested for histamine or discarded.
Lastly, each of your corrective action plans must ensure how the cause(s) of each deviation will be corrected. For example, in addition to adjusting temperature settings on equipment, your firm should also make repairs to that equipment when necessary.
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 123.1 (b). However, your firm did not monitor the proper labeling, storage, and use of toxic compounds; and the exclusion of pests from the food plant with sufficient frequency to ensure control, as evidenced by:
A. Proper labeling, storage and use of toxic compounds.
i. On 8/10/10, an employee was observed spraying the stainless steel table used to hold smoker racks with an unknown clear liquid from an unmarked plastic spray bottle in which the employee stated contained “sanitizer”. Our investigator was informed this clear liquid was “ (b)(4)”. And on 8/11/10, the unmarked bottle was observed containing a yellow liquid in which the investigator was informed was “ (b)(4) ”.
We acknowledge your letter stating that unmarked spray bottles were labeled on August 16, 2010. Our investigator observed you labeled them as “ (b)(4) ”. This corrective action does not appear to be adequate to address the noted observation because it appears your firm uses two different types of sanitizers. You must distinguish each bottle with appropriate labeling for each.
ii. On 8/10/10, an employee was observed pouring a sanitizer “ (b)(4) ” directly from its bottle onto fillet knives which are used as food utensils to cut fish. The manufacturer’s label for this sanitizer included instructions which stated: “Do not use on utensils”. Additionally, for food processing plants, the sanitizer is to be first diluted with water and food contact surfaces must then be rinsed with potable water.
iii. Our investigator measured the concentration of sanitizer from a spray bottle in the processing area and found it to be greater than 1000 ppm. During the inspection, you informed our investigator that your target dilution concentration is 200 ppm. When asked how employees dilute “ (b)(4) ”, an employee stated that he uses one capful of sanitizer and fills the spray bottle with water. The volume of the water used for dilution was unknown by your firm. When mixed how the employee described, the concentration was measured to be greater than 1000 ppm.
We acknowledge your letter stating that employees were instructed to dilute sanitizers to appropriate strength and use the test strips to ensure correct dilution. Your corrective action does not adequately address the noted observation because it did not ensure that the problem of employees pouring the sanitizer directly from its bottle onto fillet knives will not recur. Furthermore, the manufacturer’s label instructed that this sanitizer is not to be used on utensils and stated that this sanitizer must be rinsed off with potable water when used in food processing plants. It appears that your firm is not using this sanitizer according to the manufacturer’s instructions for use in food processing establishments. When exceeding the manufacturer’s limitations for use, the sanitizer may be considered an adulterant in foods or food contact surfaces. Proper training of employees responsible for the mixing and/or use of sanitizing solutions is essential.
B. Exclusion of pests.
i. At least 5 live flies were observed in the processing, packaging, and raw ingredient storage areas.
ii. At least 50 dead flies were observed to be adhered to one-side of a fly strip hanging in the processing area.
iii. One fly was observed landing on the edge of a partially opened bag of brown sugar.
iv. Spider webs were observed on the corner of light fixtures directly above the area where ready-to-eat smoked salmon was being packaged and in the processing area where brined and cooked salmon were being processed.
We acknowledge your letter stated that you have changed the (b)(4) sticky pad and hung two additional fly strips. You also stated that the spider webs were removed during the inspection and will monitor in your SSOP by regular removal. Prior to the conclusion of the recent inspection of your firm, our investigator verified that the spider webs were removed. However, we find that your response does not adequately address the noted observation regarding flies, in that it does not address how you will prevent the entrance of flies and other pests into the processing, packaging, and raw ingredient storage areas.
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. We acknowledge receipt of your response dated August 18, 2010, responding to the FDA-483 issued on August 13, 2010. Your response did not include a copy of your revised HACCP or any monitoring records associated with the revisions made to that plan, consequently we are unable to evaluate the adequacy of either your plan or your implementation. We will verify the adequacy of your implemented corrections during our next inspection.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done, since your August 18, 2010 correspondence, 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 reply to the Food and Drug Administration, Attention: Juliane Jung-Lau, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issues in this letter, please contact Ms. Jung-Lauat (510) 337-6793.
Sincerely,
/S/
Barbara J. Cassens
District Director
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