Inspections, Compliance, Enforcement, and Criminal Investigations
Foremost Foods International, Inc. 1/25/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
RETURN RECEIPT REQUESTED
January 25, 2011
Mr. William Go, President
Foremost Foods International, Inc.
2883 Surveyor St.
Pomona, CA 91768-3251
Dear Mr. Go:
We inspected your seafood importer establishment, located at 2883 Surveyor St., Pomona, CA from October 1 through November 2, 2010. 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. 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.
Seafood HACCP Regulation:
Your significant violations were as follows:
1. You must implement product specifications and an affirmative step which ensures 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). However, your firm does not have product specifications for all of your imported fish products; and, does not have an affirmative step for all foreign suppliers of your fish products.
We acknowledge receipt of your November 15, 2010 response letter. However, the specification sheet (page 11) included with the letter does not list all of the Hazards associated with all of the fishes you identify as handling. Also, as an affirmative step, the letter contained a (b)(4) issued certificate indicating that your (b)(4) supplier, (b)(4) followed the US FDA seafood HACCP regulation. However, that was the only affirmative step listed in the letter, even though you purchased product from the (b)(4) company, (b)(4).
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm’s HACCP plan intended to cover all products you handle at you facility lists monitoring procedure(s)/ frequency at the receiving and storage critical control points that are not adequate to control histamine formation and pathogen growth and toxin formation. The HACCP plan does not list the frequency of the checks, the method of obtaining the temperatures, and who will obtain these temperatures.
3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans listed in your HACCP plan at the receiving and storage critical control points to control histamine formation and pathogen growth and toxin formation are not appropriate. Specifically:
At the receiving critical control point (CCP) for temperatures between (b)(4), your HACCP plan does not ensure that adulterated product does not enter into commerce and does not correct the cause of the deviation by
• rejecting potentially unsafe product,
• cooling the potentially unsafe product that was accepted when exceeding the temperature critical limit (CL) by up to (b)(4) and moving it to the cooler to lower the product temperature below the CL, and
• not assessing the supplier or discontinuing use of the supplier.
At the storage CCP for temperature abused product, the corrective actions as written are incomprehensible.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act (21 U.S.C. § 331(dd). Our records indicate that, to date, your facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
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.
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 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.
Please send your reply to:
U.S. Food and Drug Administration
Attn: Blake Bevill, Director of Compliance
Los Angeles District
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Dr. William Vitale, Compliance Officer at 949-608-2919
Alonza E. Cruse
Los Angeles District