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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fabulous Fish Co. 02-Dec-05

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

Public Health Service
Food and Drug Administration

 

Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913) 762-2100


December 2, 2005

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
Ref. KAN 2006-07

Mr. Victor Lee, President/Owner
Fabulous Fish Company
13560 Northwest Industrial Drive
Bridgeton, Missouri 63044

Dear Mr. Lee:

We inspected your seafood processing facility, located at 311 Charlotte Street, Kansas City,
Missouri 64106-1128 between August 30, 2005 and September 20, 2005. We, collected one sample during this inspection and received the laboratory analyses on September 16, 2005. 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, 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 scombroid species fish and ready-to-eat crab products, as well as refrigerated ready-to-eat (RTE) Seafood Salad packaged in hermetically sealed plastic containers, vacuum packaged refrigerated raw swordfish, raw refrigerated trout fillets packaged in hermetically-sealed containers, and vacuum-packaged frozen salmon fillets 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:

• You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However, your firm does not have HACCP plans for refrigerated ready-to-eat (RTE) Seafood Salad packaged in hermetically sealed plastic containers, vacuum packaged refrigerated raw swordfish, raw refrigerated trout fillets packaged in hermetically-sealed plastic containers, and vacuum-packaged frozen salmon fillets to control the food safety hazard of Clostridium botulinum. You were observed storing these high-risk products in your cooler, as well as thawing the frozen vacuum-packaged salmon, prior to distribution.

• You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(l). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for "whole/processed raw fish (histamine)", does not list the food safety hazard of Clostridium botulinum associated with the vacuum packed raw refrigerated mahi mahi and the refrigerated anchovies packaged in hermetically sealed containers. We observed your firm storing both of these products in your cooler during our recent inspection. The mahi mahi appeared to be in the process of thawing, which causes the hazard of Clostridium botulinum to be reasonably likely to occur with that product due to time/temperature abuse.

• You must have a HACCP plan that, at a minimum, lists the 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 reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for "cooked, ready-to-eat crab products" lists a critical limit at the receiving critical control point that is not adequate to control "pathogen growth temperature abuse." Specifically, your critical limit states that you will take core temperatures of at least [redacted] While monitoring the core (or surface temperature of a representative number of containers at receiving is adequate when transit times are short, taking temperatures of products at receipt will not ensure that the products were continuously held at the proper temperature during extended transport times (i.e., when transport times exceed 4 hours.

• You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for scombroid species fish lists a monitoring frequency at the storage critical control point that is not adequate to control scombrotoxin formation. Specifically, product temperatures, or cooler temperatures, should be monitored continuously with a visual check of the equipments daily . Your current monitoring frequency, [redacted] is not adequate because it does not control the hazard of scombrotoxin formation during those times when the temperature is not being monitored.

• Because you chose to include a corrective action plan in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for cooked ready-to-eat crab products at the receiving and storage critical control points to control pathogen growth are not appropriate. Testing product that has been received without sufficient ice or cooling media is not an adequate corrective action. Additionally, the [redacted] temperature listed as the threshold for testing for the corrective action at the storage critical control point is inadequate. For additional information on appropriate corrective actions associated with pathogen growth in ready to eat seafood products, please refer to Chapter 12 of the Fish and Fisheries Products Hazards & Controls
Guidance.

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 reply to the Food and Drug Administration, Attention: Joseph G. Kramer, Compliance Officer, 11630 West 80th Street, Lenexa, KS 66214-3340. If you have any questions regarding any issue in this letter, please contact Mr. Kramer at (913) 752-2719.

Sincerely,

/S/

John W. Thorsky
District Director
Kansas City District