Inspections, Compliance, Enforcement, and Criminal Investigations
Fuji Food Products Inc 10-Oct-07
Department of Health and Human Services
Denver District Office
October 10, 2007
RETURN RECEIPT REQUESTED
Mr. Kenny Y. Sung
Fuji Food Products, Inc.
1116 North Armando Street
Anaheim, California 92806
Ref. #: DEN-08-04 SW3
Dear Mr. Sung
An investigator with the U.S. Food and Drug Administration inspected your seafood, processing facility, located at 5691 E. 56th Avenue, Commerce City, Colorado, on May 14 through May 30,2007. 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 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 ready-to-eat sushi product containing Seafood such as surimi, tuna, and salmon is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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.
The significant violation we noted at your firm during our recent inspection was as follows:
You must fully document, in records, all corrective action 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 [redacted] for seafood-containing sushi products at the Storage Final Products critical control point. For example, on 05/08/07 your finished product storage cooler, [redacted] exceeded your listed critical limit to temperatures above [redacted] for approximately eighteen (18) hours. On 05/08/07, your Surimi Roll Combo was produced and finished product was stored in this cooler overnight until loaded on a truck for shipment the next day, 05/09/07. In addition, temperature recording charts for 05/08/07 show your finished product cooler appears to have been between [redacted] for approximately 12 hours that-day. Although your facility manager stated corrective action was taken, no documentation exists to show what corrective action was taken and whether temperature abused product was subsequently shipped.
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.
This letter may not list all the violations at your facility. We acknowledge receipt of your written response dated June 18, 2007, and will verify implementation of the outlined corrective actions during our next inspection of 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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Nancy G. Schmidt, Compliance Officer, P.O. Box 25087, Denver, CO 80225. If you have questions regarding any issues discussed in this letter, please contact Ms. Schmidt at the address noted above.
B. Belinda Collins
Director, Denver District