• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

C. Kenneth Imports Co Inc 16-Nov-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Public Health Service
Food and Drug Administration

 

New York District
158-15 Liberty Avenue
Jamaica, NY 11433


November 16, 2001

WARNING LETTER

Ref: NYK-2002-14

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Kang. Jung
President
C. Kenneth Imports Co., Inc.
150th Street & Exterior Street
Bronx, NY 10451

Dear Mr. Jung:

We inspected your seafood processing facility, located at 150th Street and Exterior Street, Bronx, NY on October 4, 2001, and found that you have serious deviations from the Seafood HACCP regulations (Title 21, Code of Federal Regulations, Part 123 (21 CFR 123)}. These deviations cause your imported seafood including repackaged ready-to-eat seafood such as dried shrimp and squid to be in violation of Section 402 (a)(4) of the Federal Food, Drug, and Cosmetic Act. You can find this Act and the Seafood HACCP regulations through the links in FDA's home page at www.fda.gov. The observations of concern to us are as follows:

1. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11 (b), and maintain sanitation control records to comply with 21 CFR 123.11
(c). However your firm failed to conduct monitoring in any of the following areas of sanitation:

(a) the safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;

(b) the condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;

(c) prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments;

(d) maintenance of hand washing and sanitizing facilities;

(e) protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;

(f) proper labeling, storage, and use of toxic compounds; and

(g) control of employee health conditions that could result in the microbiological
contamination of food, food packaging materials, and food contact surfaces.

2. As an importer of fish or fishery products such as pollock, shrimp and squid, your firm fails to have and implement written verification procedures for ensuring that the fish and fishery products that you offer for import into the United States were processed in accordance with the requirements of 21 CFR 123,12. For example:

(A) Your firm fails to have product specifications in accordance with 21 CFR 123.12 (a)(2)(i) that are designed to ensure the product is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act because it may be injurious to health or have been processed under insanitary conditions.
(B) Your firm fails to have one, or more of the affirmative steps required in 21 CFR 123.12
(a)(2)(ii) to provide a level of assurance of compliance with HACCP requirements. Affirmative
steps may include the following:

(a) obtaining from the foreign processor the HACCP and sanitation monitoring records-that relate to the specific lot... offered for import;

(b) obtain either a continuing or lot-by-lot certificate from an appropriate foreign government... or third party...;

(c) regularly inspect the foreign processor's facilities...;

(d) maintaining on file a copy, in English, of the foreign processor's HACCP plan, and a written guarantee from the foreign processor that the imported fish or fishery product was processed in accordance with.... (Seafood HACCP);

(e) periodically testing the imported fish or fishery product, and maintaining on file in English, a written guarantee from the foreign processor that the imported fish or fishery product was processed in accordance with...(Seafood HACCP); and

(f) other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of this part.

We may take further action if you do not promptly correct these deviations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

Please respond in writing within 15 days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

This letter and the inspectional observations (Form FDA 483) issued to and discussed with Donwon Kim, General Manager, at the conclusion of the inspection, may not list all the deviations at your facility. You are responsible for ensuring that your seafood processing facility operates in compliance with the Act, the Seafood HACCP regulations and the Good Manufacturing Practice regulations (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 Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have questions regarding any issues in this letter, please contact Ms. Aveta at (718) 662-5576.

Sincerely,

/S/

Jerome G. Woyshner
District Director

Enclosure: Form FDA 483 dated October 4, 2001

cc: Mr. Donwan Kim
General Manager
C. Kenneth Imports Co., Inc.
150th Street & Exterior Street
Bronx, NY 10451