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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pacific International Seafood, LLC 01-Mar-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700



VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Our Reference: FEI 3005181731

March 1, 2007


Dick S. H. Kim, Member
Pacific Intentional Seafood, LLC
22S N. Nimitz Highway
Honolulu, Hawaii 96817


WARNING LETTER

Dear Mr. Kim,

We inspected your seafood processing and importer establishment, Pacific International Seafood, LLC, located at 225 N. Nimitz Highway, Honolulu, Hawaii, on November 21 and 29, 2007. We found that you have serious violations at the seafood Hazard Analysis and Critical Control Paint (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 114 (21 CFR Parts 123 & 110).

As a domestic processor of fish and fishery products, failure to have and implement a HACCP plan that complies with 21 CFR 123 .6(g), or otherwise operate in accordance with the requirements of 21 CFR Part 123, renders the fish ar fishery products adulterated within the meaning of Section 442{a}(4) of the Federal Food, Drug, and Cosmetic Act {the Act), 21 U.S.C. § 342(a}(4}.

As an importer of fish and fishery products, you must also operate in accordance with the requirements of 21 CFR part 123. The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12, 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 exists that the imported fish and fishery products have
been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 4Q2{a){4) of the Act, 21 U.S.C. § 342(a){4).

Accordingly, your [redacted] yellowtail and your vacuum packaged yellowtail fillets 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 conduct or have conducted far you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.b{a) and (b), However, your your firm does not have a HACCP plan for:

a) Refrigerated, [redacted] yellowtail, to control the food safety hazard of histamine formation as a result of time/temperature abuse during the receipt, re-packing, and storage of the product at your facility; and

b) Refrigerated, vacuum packaged yellowtail [redacted], to control the food safety hazard of histamine formation and Clostridium botulinum toxin formation as a result of time/temperature abuse during the receipt, re-packing, storage, and distribution of the product.

2) You must implement 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(2)(a)(2)(ii). However, your firm did not perform an affirmative step far the refrigerated, [redacted] yellowtail fish and the refrigerated, vacuum packaged yellowtail [redacted] processed by [redacted].

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. 350(d) 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, ar 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-O156, or by writing to the agency at the following address:

U.S. Food and Drug Administration, HFS-681
56U0 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 and 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 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 importer HACCP and verification records, records that document the performance and results of your firm's affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 establishment operates in compliance with the Act, the Seafood HACCP regulation, and the Current Good Manufacturing Practice regulation. 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: Ms. Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. if you have any questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.

Sincerely,

/S/

Gordon Cox
Acting District Director
San Francisco District