- Wang Globalnet
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
July 31, 2014
WARNING LETTER NYK-2014-52
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUEST
Mr. Sungheon Kang, Owner/Chief Executive Officer
2465 Fruitland Avenue
Vernon, CA 90058
Dear Mr. Kang;
We inspected your seafood importer establishment, located at 365 Ten Eyck St., Brooklyn, NY 11206 on April 22, 2014 and April 25, 2014. 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
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 a serious violation for 21 CFR Part 123, your boiled and dried anchovy product is adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), 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
Your significant violation was as follows:
- You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation, to comply with 21 CFR123.12(a)(2)(ii). However, your firm did not completely implement an affirmative step for your boiled and dried anchovy product manufactured by (b)(4), located in (b)(4).
On (b)(4), FDA collected a sample of your boiled and dried anchovy product manufactured by (b)(4), in (b)(4) that was offered for import under entry number (b)(4). Your boiled and dried anchovy product, (b)(4), was adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) in that FDA laboratory analysis found the product to be uneviscerated. The entry was refused admission on (b)(4).
The FDA Compliance Policy Guide (CPG) Section 540.650, Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked, provides further guidance. You may access the CPG through links on FDA's home page at www.fda.gov
In addition, we have determined that your facility is subject to the biennial registration renewal requirement in § 415(a)(3) of the Act, 21 U.S.C. § 350d(a)(3), which requires submission of a renewal registration during the period beginning on October 1 and ending on December 31 of each even-numbered year, and our implementing regulation at 21 CFR Part 1, Subpart H. During the current inspection of your facility, you were advised of this requirement. The failure to re-register a facility as required is a prohibited act under § 301(dd) of the Act, 21 U.S.C. § 331 (dd). Our records indicate that, to date, this facility has not been re-registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request you register your facility with FDA within 30 working days of the date of this letter. 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, you 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
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.
Although a written response was promised at the close of the inspection to address the form FDA 483, Inspectional Observations, we have not yet received your written response.
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.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433, Attention: Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact Kristen Jackson at 718-662-5711.
Ronald M. Pace
New York District