Mutual Trading Company Inc
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
September 30, 2010
Noritoshi Kanai, President
Mutual Trading Company, Inc.
431 Crocker Street
Los Angeles, California 90013-2114
Dear Mr. Kanai:
We inspected your seafood processing / importer / distribution facility, located at the above shown location, on May 17th through May 25th of 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point ( henceforth “HACCP” ) regulation, Title 21, Code of Federal Regulations ( henceforth “CFR” ), Part 123, and the Current Good Manufacturing Practice ( henceforth “CGMP” ) regulation for foods in Title 21, CFR parts 110 & 123. 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 ( henceforth “the Act” ), 21 U.S.C. § 342(a)(4).
Accordingly, the various seafood products containing characterizing fishery products you process 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 and Controls Guidance through links at the U. S. Food and Drug Administration’s ( henceforth “FDA” ) home page at www.fda.gov
Your significant violations were as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind 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 pasteurized refrigerated imitation crab meat in an oxygen-reduced package.
2. 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 Mackerel with (b4) lists a CCP of (b4) and another CCP for (b4) for monitoring the refrigerator temperature to prevent C. botulinum toxin formation using a digital probe thermometer with a visual check of (b4) times a day. This method does not ensure that proper temperatures will be continuously be maintained between temperature checks and during those times when your firm is not open for business, such as overnight. FDA recommends that cooler storage temperatures be monitored with equipment that is capable of continuously monitoring temperatures and that the equipment is capable of providing a record of the temperatures or is equipped with an alarm system that provides a 24 hour alert.
3. You must implement the record keeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm’s HACCP plan stated a monitoring procedure of (b4) times a day but they were only monitoring (b4) times a day from April 14 until May 3, 2010. Also this same HACCP plan for Mackerel with (b4) at the critical control point for (b4), and the critical Control Point for (b4), states a verification procedure of (b4) of recording thermometer”. The critical control point for “Finished product freezer storage” states a verification procedure of “check calibrated thermometer (b4),” and the critical point for Freezer Storage states “Check with calibrated Thermometer (b4)”, You are not calibrating your continuous recording chart thermometers or digital probe thermometers. You must implement the calibrating of your continuous recording chart thermometers and digital probe thermometers that you listed in your HACCP plans, to comply with 21 CFR 123.6(b).
4. You must fully document in your records all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical limit of “Maintain Refrigerator Temperature below (b4)” for Mackerel w/ (b4) at the (b4) and (b4) critical control points to control “Pathogen growth and C. botulinum toxin formation.” On numerous occasions your refrigerator temperatures were recorded above 37° F, including above 40° F.
5. You must maintain sanitation control records that, at a minimum, document monitoring and corrections as set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation control records required for the processing of frozen mackerel intended to be consumed raw by the consumer. Specifically, on May 18, 2010 our investigator observed your firm’s handling of frozen mackerel; however, no sanitation control record was maintained.
6. 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 prevention of cross-contamination from insanitary objects to food and the exclusion of pests from the food plant with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the following observations:
a. On 5/17/10, a rusted hammer was observed in the seafood processing room. The hammer was used to break up ice which came in direct contact with frozen mackerel. The mackerel is intended to be eat raw.
b. On 5/17/10, a cutting board was observed to be gouged and visibly soiled with a brown organic substance. We observed the cutting board used to fillet mackerel.
c. On 5/20/10, a wooden spatula was observed in the processing room. The wooden spatula had visible gouges in the wood which doesn’t allow the spatula to be cleaned. The spatula was used to manufacture various vinegar solutions which are ingredients in ready to eat seafood products.
d. On 5/20/10, a live cockroach was observed inside the processing room.
In addition, it is important that your sanitation control records accurately reflect the conditions and practices at your firm, as required by the 21 CFR 123.11(b).
7. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12.(a)(2)(ii). However, your firm did not perform an affirmative step for (b4) tuna, (b4) mackerel, (b4) anchovy and (b4) bonito products that you import from (b4).
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.
Your written reply should be addressed to:
Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild Rd.
Irvine, California 92612-2506
Alonza E. Cruse
Director, Los Angeles District
Food and Drug Branch
California Department of Public Health
1500 Capital Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413