- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameMr. Tai Wong
- Chaur Fong Inc. dba 888 Food Company
2111 Chico Ave
South El Monte, CA 91733
- Issuing Office:
- Office of Human and Animal Food Operations – West Division 5
July 29, 2022
Dear Mr. Wong:
We inspected your seafood processing facility, located at 2111 Chico Ave, South El Monte, CA 91733 on June 9 through 28, 2022. 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 Ho King brand Featherback Fish Balls and Giai Phat brand Fish Balls 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 hazard." However, your firm’s HACCP plan for Refrigerated Seafood RTE Products, including Ho King brand Fried Fish Balls, does not list a critical limit(s) at (b)(4) Stage critical control point to control Clostridium botulinum toxin formation.
Specifically, your critical limit does not list maximum thickness of packaged fish products in accordance with your validated study. We reviewed your FDA 483 response received on July 5, 2022, and have determined it is not adequate. Your response does not list a critical limit that specifies the maximum or minimum value of packaged fish product’s thickness, and the corresponding monitoring procedures and the recordkeeping system that will document the monitoring of the critical control point. Furthermore, you did not provide documentation demonstrating that you are monitoring maximum thickness of the packaged fish products.
2. You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for Frozen Products, including your Giai Phat brand Featherback Fish Balls, does not list the critical control point of frozen storage with labeling for controlling the food safety hazard of Clostridium botulinum toxin formation.
We reviewed your FDA 483 response received on July 5, 2022, and it is inadequate because you did not provide an updated HACCP plan that includes the control and its corresponding monitoring, corrective actions, and verification procedures. Furthermore, you did not provide documentation demonstrating that you are controlling the hazard.
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 response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Irvine, CA 92612
Refer to Unique Identification Number 638521 when replying.
If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov or 510-337-6870.
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5