Inspections, Compliance, Enforcement, and Criminal Investigations
Fujian Sky Food Company 23-Dec-05
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
December 23, 2005
Cheng Cheng Shao, President/Owner
Fujian Sky Food Company
1425 S. Marguerita Ave., Apt. L
Alhambra, CA 91803-3138
Dear Mr. Shao:
The Food and Drug Administration (FDA) concluded an inspection of your seafood importer establishment, located at 1425 S. Marguerita Ave., Apt. L, Alhambra, CA 91803-3138, on October 13, 2005. 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 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123 . If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry. Because our inspection identified serious violations of 21 CFR Part 123, your frozen raw oyster, jellyfish, and eel imported from [redacted] are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), 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 Product Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must have and implement product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health and have not been processed under insanitary conditions, to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have a product specification for frozen raw oyster, jellyfish, and eel imported from [redacted]
2. You must implement affirmative steps to ensure 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 affirmative steps for frozen raw oyster jellyfish, and eel manufactured by [redacted] in [redacted]
In addition, on September 12, 2005, FDA Investigators began examining entries [redacted] and [redacted] and discovered that these entries consisted of a significant amount of undeclared products for which Prior Notice was not submitted pursuant to 21 CFR 1.280 and Section 801(m) of the Act, 21 U.S.C. § 381(m). Failure to adhere with these regulations is a prohibited act under Section 301(ee) of the Act, 21 U.S.C § 331(ee).
Our inspection also found discrepancies in entries [redacted] and [redacted] as declared with respect to, the. quantity, type, and manufacturer of the products therein. Specifically, entry [redacted] declared only three products: dried bean, jellyfish peel, and frozen fish. Our inspection revealed that this shipment actually contained approximately 20 different products, including dried fish two types of jelly fish, fish balls. soybeans, cuttlefish, Chinese fruit, peanuts, oysters, eel, raw duck carcass, canned food items, and various other unidentified seafood products. The entry documentation also declared that the manufacturer was [redacted] but none of the products found in the shipment appeared to be from manufacturer.
Entry [redacted] also declared only three products: dried noodle, fruit beverage, and pickles. Our inspection revealed that this shipment actually contained approximately 100 different products, including peanuts, tea drinks, alcohol beverages, vegetables, cookies, crackers and canned food items. The entry documentation declared the manufacturer was [redacted] but none of the products found in the shipment appeared to be from that manufacturer.
Many of the undeclared products in these shipments are currently listed on Detention Without Physical Examination (DWPE) under the following Import Alerts: Import Alert 02-02 - Rice-Based Products Due To Filth; Import Alert 21-04 - Dried Fruits; and Import Alert 25-05 Dried Fungus (Mushrooms) From Hong Kong and Proc For Filth. Additionally, most of the master cartons in shipment [redacted] were not labeled in English with a product name and those that were, were not labeled properly. The majority of the products in shipment [redacted] did not list manufacturers in English or the manufacturers listed in Eng1ish were not as declared. Many of the undeclared canned food products in these shipments are subject to FDA's regulations for hermetically sealed Acidified and Low-Acid Foods, 21 CFR 108.25(j) and 108.35(k).
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on - "detention without physical examination," seize your product(s), and/or enjoin your firm from further violating the Act. In addition, under your firm's current conditions, FDA will not issue any Certificates for Export or European Union Health Certificates for any of the affected fish and fishery products processed at your facility.
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 importer verification records and records that document the performance and results of your firm's affirmative steps, 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 of the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Your written reply should be directed to:
U.S. Food & Drug Administration
Attn: J. Lawrence Stevens
Director, Import Operations Branch
222 West 6h Street, Suite 700
San Pedro, CA 90731
If you have questions regarding any issues in this letter, please contact Ruth P. Dixon, Compliance Officer, at (310) 971-2299.
Alonza E. Cruse