- Kilim Nong San
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
SEP 25, 2014
VIA EXPRESS DELIVERY
Mr. Jae Hyun Park, CEO
Kilim Nong San
301-25 Sosa-bon 3 dong
Reference No. 436874
Dear Mr. Jae Hyun Park:
The U.S. Food and Drug Administration (FDA) inspected your acidified food facility located at 301-25 Sosa-bon 3 dong, Pucheon-si, Kyungki-do, Korea on June 17-18, 2014. During that inspection, we found that your firm had a serious deviation from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108, (21 CFR 108)). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, which lists the serious deviations found at the firm. We acknowledge receipt of your response to the FDA-483 on July 17, 2014; however, review of your response and related documentation revealed that your firm has not made adequate corrections, as further described in this letter.
As a manufacturer of acidified food products intended for export into the United States, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and all applicable federal regulations. Regulations specific to the processing of acidified foods are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 114, Acidified Foods. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. In addition, violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR 114 renders your acidified food products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). You can find the Act and the acidified food regulations through links in FDA’s home page at www.fda.gov
Your significant violation is that your firm failed to ensure acidified foods are manufactured in accordance with the scheduled process as required by 21 CFR 108.25(c)(3)(i). Specifically, your firm’s scheduled processes for (b)(4) identify citric acid as an ingredient, a final (b)(4), and a post filling hot water immersion for (b)(4). Our inspection revealed your firm is not adding citric acid, not measuring pH, cooking product at (b)(4), and no post-fill hot water immersion is occurring.
We acknowledge that your response via email dated July 17, 2014 includes information that you are now adding citric acid and measuring the pH of the following products: (b)(4). However, your response did not include supporting documentation, such as processing records, showing your adherence to your scheduled processes. In addition, we acknowledge that your response included microbiological test results for Escherichia Coli for approximately a year in support of your current cook time and temperature; however, such test results do not substitute for the establishment of a valid process established by a processing authority.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported acidified food products under Section 801(a) of the Act, 21 U.S.C. 381(a), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the acidified food regulations (21 CFR 108 and 114) is Import Alert #99-38. This alert can be found on FDA’s web site at: www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm
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 and all applicable regulations, including the acidified food regulations (21 CFR 108 and 114) and the Good Manufacturing Practices regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, 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. 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 foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign 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 reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Catherine Vieweg, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Catherine.Vieweg@fda.hhs.gov
. Please reference #436874 on any submissions and within the subject line of any emails to us. You may also contact Catherine Vieweg via email if you have any questions about this letter.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition
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