|Company:||CT Concerns, Inc. dba Ocean Harvest|
|Subject:||CGMP for Foods/Seafood HACCP/Adulterated|
|Issuer:||Los Angeles District Office|
|Issued:||Feb. 15, 2006||Closed:||
Department of Health and Human Services
Public Health Service
LOS Angeles District
RETURN RECEIPT REOUESTED
February 15, 2006
Mr. Minkyu Park, President
CT Concerns, Inc. dba Ocean Harvest
7595 Vickers Street, Suite A
San Diego, CA 92111-1549
Dear Mr. Park:
We inspected your seafood processing facility, located at 7595 Vickers St., Suite A, San Diego, CA 92111-1549 on November 30 - December 1, 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 Fresh Tuna, Yellowtail, Mackerel, Amberjack and Atlantic salmon 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 implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the "Receiving and "Storage" critical control points to control Histamine contamination and formation listed in your HACCP plan for Fresh Tuna, Yellowtail, Mackerel, and Amber Jack. Specifically, there are no CCP records for "Receiving" and"Storage" as specified in your HACCP plan. According to your HACCP plan, the visual ice exam for the "Receiving" and "Storage" CCP's are to be recorded on the Receiving records and the Cooler teinp.log.
2. 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) (1). 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 Fresh Tuna, Yellowtail, Mackerel, and Amber Jack intended for raw consumption does not list the food safety hazard of pathogen growth.
3. 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 a HACCP plan for the fresh farmed Atlantic salmon intended for raw consumption to control the food safety hazard of pathogen growth. Alternatively, in lieu of a separate HACCP plan to address the pathogen hazard for fresh farmed Atlantic salmon, you may group this fish with your current HACCP plan to control pathogens in accordance with 123.6(b).
4. 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 that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; and proper labeling, storage and use of toxic compounds with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. An employee processing fresh Atlantic salmon intended for raw consumption used a hose to rinse the wall behind the filleting table while the fresh salmon was on the filleting table; water splashed from the wall directly onto the fresh salmon.
b. There was a personal beverage container and a strip curtain in a bin of ice that is used in direct contact with fresh fish intended for raw consumption.
c. The food contact surfaces of the three cutting boards on your filleting table are scored/worn, creating an unsmooth and stained food contact surface. These cutting board surfaces come in direct contact with fresh fish intended for raw consumption.
d. Processing utensils soiled with fish scales and fish meat residues were stored in a wall mounted rack, including a fillet knife, a shellfish shucking knife, scale removers, a spoon, and a knife sharpener. Also, a fillet knife containing a build-up of filth at the blade / handle juncture was used to process fresh salmon and fresh tuna intended for raw consumption.
e. Fresh raw tuna was stored above unsealed cardboard cartons of ready-to-eat radish sprouts in your walk-in cooler, and blood dripped from the tuna onto a carton of radish sprouts near holes in the carton top.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act (21 U.S.C. § 331(dd). Our records indicate that, to date, your facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by Your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration maybe accomplished on-line at http://www.access.fda.gov . We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4) and the seafood HAACP regulation. We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H.
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), and is registered in accordance with the Food Facility Registration regulation (21 CFR Part 1, Subpart H). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
If you have any questions relating to this letter please contact MaryLynn Datoc at 949-608-4428.
Your written reply should be addressed to:
Pamela B. Schweikert
Director, Compliance Branch
Irvine, CA 92612-2445.
Alonza E. Cruse