WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
November 30, 2009
W/L 03-10
Mr. Henry Wong, President
Chaur Fong, Inc., dba 888 Food Company
2111 Chico Ave
South El Monte, CA 91733-1606
Dear Mr. Wong:
We inspected your seafood processing facility, located at 2111 Chico Ave., South El Monte, CA from August 12 – 19, 2009. 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 seafood products, which include ready-to-eat fish GIAI PHAT featherback fish “balls”, “cakes”, and “loafs” and cooked seafood products such as HA GAO Shrimp Dumplings and frozen Featherback Fish Paste, 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 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 hazards.” Your firm’s HACCP plan for “fully cooked, not shelf stable fish products: cuttlefish ball, fish ball, fried fish ball fish cake (patty), fish loaf” lists critical limits at the “cooking” critical control point that are not adequate to control the hazard of “C. botulinum”, which is listed as
a reasonably likely hazard in your plan.
Specifically, a cook that achieves an “internal product temperature of at least (b)(4) minimum” is not adequate to achieve a 6D log reduction for Clostridium botulinum. According to Table #A-4 in the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition, a cook time of 51.8 minutes at a minimum internal temperature of at least 185 degrees F is necessary for inactivation of non-proteolytic Clostridium botulinum type B.
Your firm should show through a validated scientific study or other reference, documentation demonstrating adequacy of the cook process, including assurances that each article of food (i.e., each meatball or loaf) receives the time/temperature cook sufficient to control Clostridium botulinum types A, B, E and F.
For additional information on the hazard of Clostridium botulinum, please refer to Chapter 13 of the Fish and Fisheries Products and Controls Guidance: 3rd Edition.
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 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). Your film does not have a HACCP plan for your firm’s HA GAO shrimp dumplings to control the food safety hazard of sulfites.
3) 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, to comply with 21 CFR 123.11(b). Your firm did not with sufficient frequency:
a. Monitor the safety of water [21 CFR 123.11(b)(1)] that comes into contact with food or food contact surfaces, including water used to manufacture ice, as evidenced by:
The water used in the manufacturing of ice and used in the manufacturing of the fishery products is not checked on daily basis.
The safety of the water used in the manufacturing of ice and used in the manufacturing of the fishery products is not monitored.
b. Monitor the maintenance of hand washing and toilet facilities [21 CFR 123.11(b)(4)], as evidenced by:
The employee hand washing station in the first seafood processing area did not have any hand soap.
The front processing area did not have an accessible hand washing sink. There was a sink for employees to use; however, it was blocked by a hose that is used during processing.
c. Prevent cross-contamination from insanitary objects to food and other food contact surfaces [21 CFR 123.11(b)(3)], as evidenced by:
Several employees were not washing their hands between contact with unclean equipment such as metal racks and handling raw materials such as raw fish paste even though hand washing stations were available.
An employee was observed scooping fish cake/loaf paste out of the large mixer. This employee’s exposed arms were coming in contact with the paste, resulting in direct cross
contamination of food products.
Two employees with goatees were observed not wearing beard covers while processing raw seafood products.
An employee was observed wearing a jade bracelet while she was manipulating raw fish loafs by hand. Her gloves were not covering her bracelet completely, resulting in direct cross contamination of food products.
We have reviewed your responses, received on August 31, 2009, and October 27, 2009 and have found them to be inadequate. Your responses do not present data or information to support your stated corrections.
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 response should be sent to:
James P. Stumpff
Acting Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact:
Dr. William Vitale, Compliance Officer at 949-608-2919.
Sincerely yours,
Alonza E. Cruse
District Director
Source: FDA