| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949·608·4415 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
W/L 08-10
January 25, 2010
Mr. Roberi Tsai
President/Co-Owner
Venus Foods, Inc.
770 S. Stimson Avenue
City of Industry, CA 91745
Dear Mr. Tsai:
We inspected your seafood processing facility, located at 770 S. Stimson Avenue, City of Industry, CA 91745, on September 10-11,16-18, and 22-23,2009. 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 Shrimp-Flavored Fish Ball and Cuttlefish Ball products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Your Venus Shrimp Flavored Fish Balls and Wei-Chuan Shrimp Flavored Fish Balls are also misbranded under Sections 403(a)(1), 403(i)(2) and 403(q)(1)(a)(i) of the Act, 21 U.S.C. §§ 343(a)(1), 343(i)(2), and 343(q)(1)(a)(i). 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 http://www.fda.gov.
During our inspection, the investigator provided you with the form FDA 483, which presents his/her evaluation of your film's performance regarding various aspects of the HACCP and CGMP requirements.
On October 10, 2009, we received your response of October 8, 2009, to the seafood HACCP deficiencies identified in the FDA Form 483. With respect to some of the items, your response appears adequate and will be verified during our next inspection.
This letter identifies the remaining deviations:
Seafood HACCP
1. You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). FDA investigators observed that your firm's continuous chart recorder was no longer in operation to monitor your listed monitoring step, "Twenty four-hour monitoring: of the cooler air temperature in order to control Clostridium botulinum toxin formation" at the "Refrigerated storage of finished product CCP4BCT" critical control point. Your response dated October 10, 2009, indicated that CCP4BCT was revised to reflect "current monitoring and documentation procedures (twice daily)." Your response does not make clear what procedure is being carried out "twice daily" and does not indicate whether your continuous monitoring equipment is currently functioning and in use. You must implement the monitoring procedures that are listed in your HACCP plan, and any modifications to that plan must comply with the applicable HACCP regulations.
Misbranding
I. Your Venus Shrimp Flavored Fish Balls and Wei-Chuan Shrimp Flavored Fish Balls are misbranded under Section 403(a)(I) of the Act [21 U.S.C. 343(a)(I)] in that the labels are false or misleading. The ingredient statements list shrimp as an ingredient; however, the evidence collected during the investigation indicated that shrimp has not been used by your firm since June 2007.
2. Your Venus Shrimp Flavored Fish Balls and Wei-Chuan Shrimp Flavored Fish Balls are misbranded under Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that they are fabricated from two or more ingredients, but their labels fail to list all sub-ingredients in descending order of predominance by weight, as required by 21 CFR 101.4. Specifically; the labels for your 'Venus Shrimp Flavored Fish Balls and Wei-Chuan Shrimp Flavored Fish Balls list Surimi as an ingredient, which is a multicomponent food, but the label does not list the sub-ingredients for the Surimi.
The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the multicomponent ingredient [21 CPR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
3. Your Venus Shrimp Flavored Fish Balls and Wei-Chuan Shrimp Flavored Fish Balls products are misbranded within the meaning of 403(q)(1)(A)(i) of the Act [21 U.S.C. 343(q)(I)(A)(i)] in that the labels fail to properly declare the serving size as specified by 21 CFR 101.9(b) and 101.12(b). Serving sizes are determined based on the Reference Amounts Customarily Consumed (RACC), which are provided by 21 CFR 101.12(b). The Venus Shrimp Flavored Fish Balls and Wei-Chuan Shrimp Flavored Fish Balls products declare the serving size as "4 pieces (51 g)." However, the RACC established for fish cakes is 85 g cooked (21 CFR 101.12 (b), Table 2, Fish, entrees without sauce, e.g.. ... fish ... cake). Under 21 CFR 101.9(b)(2)(i)(A), the serving size for products in discrete units that weigh 50 percent or less of the RACC is the number of whole units that most closely approximates the RACC. For these products the number of whole shrimp flavored fish balls that most closely approximates the RACC is seven (7) fish balls. Because the nutrition information is based on four (4) fish balls instead of 7 fish balls, the nutrient information declared on the label is not correct for the serving size.
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 that you are doing to correct these violations. You should include in your response documentation such as your HACCP plan and monitoring records, revised product labeling, 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.
It is clear from the ingredient formulation, as well as from the assertions made by your firm during the course of the inspection, that the "shrimp flavor" in the Venus Shrimp Flavored Fish Balls and Wei-Chuan Shrimp Flavored Fish Balls is not derived from a shrimp ingredient. Therefore, if you continue to make representations with respect to shrimp being the primary recognizable flavor of these products,the products must be labeled either with the flavor of the product from which the shrimp flavor is derived or as artificially shrimp flavored [21 CFR 101.22(i)(1)(ii)]. Under the second altenative, the labeling must conform to the standards set forth in 21 CFR 101.22(i)(2) and (i)(3).
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 CPR Part 123), the Current Good Manufacturing Practice regulation for foods (21 CPR Part 110), and the labeling requirements for foods (21 CFR Part 101.) 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: Acting Director of Compliance Branch, 19701 Fairchild, Irvine, CA 92612. If you have questions regarding any issue in this letter, please contact Compliance Officer Scott Goff at (949) 608-4433.
Sincerely,
/s/
Alonza E. Cruse
Director
Los Angeles District
Cc: Mr. Stanley Chow
Vice-President, Co-Owner
770 S. Stimson Avenue
City of Industry, CA 91745
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413
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