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  5. 5000 Years Food, Inc. - 04/24/2015
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WARNING LETTER

5000 Years Food, Inc.


Recipient:
5000 Years Food, Inc.


United States

Issuing Office:
Chicago District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863 

 

April 24, 2015
WARNING LETTER
CHI-4-15
 
 
DELIVERD VIA UPS NEXT DAY & EMAIL
SIGNATURE REQUIRED
 
Mr. Sang C. Hong
President
5000 Years Food, Inc.
3465 N. Kimball Ave.
Chicago, IL 60618
 
Dear Mr. Hong:
 
On January 21 through February 12, 2015, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 3465 N. Kimball Ave Chicago, IL 60618. The inspection revealed that you have serious violations of the seafood Hazard Analysis and Critical Control Point (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 110 (21 CFR 110). 
 
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your kimchi, fried anchovy, fried file fish, fried squid, and seasoned pollock products 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 are as follows:
 
Seafood HACCP Violations
  • You must conduct or have conducted for you a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product processed to comply with 21 CFR 123.6 (a). A food safety hazard is defined in 21 CFR 123.3 (f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” Your company lacks a written hazard analysis for fried file fish, fried squid, fried anchovy, and seasoned dried pollock.
  • You must have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur to comply with 21 CFR 123.6(b). However, you do not have a HACCP plan for fried anchovy banchan to control the hazard of histamine and pathogenic growth. Additionally, you do not have a HACCP plan for fried file fish banchan and fried squid banchan to control the hazard of pathogenic growth from temperature abuse and pathogenic bacteria from survival through cooking and pasteurization.
  • You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions, and exclusion of pests to comply with 21 CFR 123.11 (b). Specifically, you are not monitoring sanitation conditions or keeping sanitation monitoring records.
CGMP Violations
  • Your procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment to comply with 21 CFR 110.35 (d)(5). Specifically, in your firm’s (b)(4) room, you do not use any detergent to clean food contact surfaces. An employee was observed placing (b)(4) in a tub of (b)(4) without measuring the amount. The utensils were added to the tub of (b)(4), scrubbed with a brush and rinsed off with a hose. The (b)(4) concentration exceeded (b)(4). In the (b)(4) room, utensils were being cleaned with detergent but the utensils were not being sanitized.
  • Your plant shall be equipped with adequate sanitary facilities and accommodations to comply with 21 CFR 110.37. It was observed during the course of the inspection:           
o     Your firm’s plumbing constitutes a source of contamination to food, water supplies, equipment, and utensils which does not comply with 21 CFR 110.37 (b)(3). Specifically, numerous hose stations were not protected against backflow. Cross connections were observed with hoses submersed in containers of water used for washing vegetables.
 
o     Your firm’s devices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands to comply with 21 CFR 110.37 (e)(4). Specifically, the handles of the hand sink in both the (b)(4) room and the (b)(4) room are covered in filth so that hands become contaminated when using the handles of the faucets. The lever and side of the paper towel dispenser in the (b)(4) room was covered in filth so that when obtaining paper towels hands would become contaminated.
  • Your firm has not taken reasonable measures and precautions to ensure compliance with 21 CFR 110.10 (b)(8). Specifically, employees were eating and preparing personal lunches in the same room used for manufacturing banchan. This room is also used for cleaning and sanitizing utensils and equipment used to prepare banchan.
  • You must maintain fixtures in repair sufficient to prevent food from becoming adulterated to comply with 21 CFR 110.35 (a). It was observed during the course of this inspection:
o   The three compartment sink in the (b)(4) room that is used for cleaning utensils is covered in rust and chipping metal. The faucet in the (b)(4) room for the hose station located near the hand sink was leaking.
 
o   The concrete floor in the (b)(4) room is deteriorated with exposed aggregate and ponding water that does not flow towards the drain. Additionally, a number of ceiling tiles are missing above the (b)(4) and (b)(4) area.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
(b)(3)(A)
  
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.
 
On March 13, 2015, you responded, via email, to the FDA-483 items from the current inspection. A review of the photographs submitted and your response is inadequate in that the photographs provided were unclear and there was no descriptive narrative to describe any corrections that may have been made as a result of the inspection.
 
(b)(3)(A)
  
We may take further action if you do not promptly correct these violations. For instance, we may take further action to 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 HACCP and verification records, 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 reinspection-related costs from the responsible party of the domestic facility. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31 (a)(2)(B)]. For a domestic facility, 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.
 
Your response should be sent to: Lauren Crivellone, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS Case #455138) when replying. If you have any questions about the content of this letter, please contact Ms. Crivellone at 312-596-4157 or email lauren.crivellone@fda.hhs.gov.
 
Sincerely,
/S/ 
Steven B. Barber
Acting District Director
Food & Drug Administration
Chicago District Office