Inspections, Compliance, Enforcement, and Criminal Investigations
Ottogi SF Corporation 11/25/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch ParkwayCollege Park, MD 20740
November 25, 2011
VIA OVERNIGHT MAIL
Mr. Ki Soo Kim, President- CEO
Ottogi SF Co. Ltd.
11, Daepyeong- ri,
Kyeong-nam, 638-802, South Korea (Republic of Korea)
Reference No: 242914
Dear Mr. Ki Soo Kim:
FDA inspected your low-acid canned food facility Ottogi SF Co. Ltd. located at 11, Daepyeong- ri, Goseong-eup, Goseong-gun, Kyeong-nam, 638-802, South Korea (Republic of Korea), on July 11- 13, 2011. During that inspection, we found that your firm had serious deviations from the low-acid canned food regulations (21 CFR Parts 108 and 113). Failure to comply with all of the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 constitutes a prima facie basis for the immediate application of the emergency permit control provisions of Section 404 of the Act and particularly implementation of 21 CFR 108.35(k) for products offered for entry into the United States. In addition, such failure renders your low-acid canned food 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 product, canned tuna, is adulterated in that the product has been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. You can find the Act and the low-acid canned food regulations through links in FDA’s home page at http://www.fda.gov.
Further, 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 canned tuna is adulterated, 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 and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov.
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge your response indicating corrective actions to the FDA-483 was received on August 2, 2011. Upon further review of the inspectional findings, documentation provided in your firm’s responses, and additional information provided during the inspection, we have the following concerns with regard to your low-acid canned seafood products:
Low-Acid Canned Food:
- Your firm failed to process each low-acid canned food in conformity with at least the scheduled process filed with FDA, as required by 21 CFR 108.35(c)(3)(i). Specifically, your firm filed thermal processes with FDA for your canned tuna in 100 gm, 150 gm, and 250 gm cans stating the cans are processed using divider plates; however, during our inspection your firm was processing the canned tuna products using gravity filled jumble loaded retort baskets. In your response dated August 2, 2011, you submitted a study demonstrating the changes (b)(4). The study you submitted does not indicate the how the cans were jumble packed, whether cans were nested, the percent (b)(4) during the study.
- Your firm failed to determine and record the initial temperature of the contents of the containers prior to processing to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process as required by 21 CFR 113.87(c). Specifically, you are not removing the coldest container of (b)(4) just prior to processing and record the (b)(4). In your written response dated August 2, 2011, you state that the (b)(4) has (b)(4); however, you did not indicate you are currently taking (b)(4) of the cans and you did not provide documentation showing the (b)(4) are in accordance with the scheduled process.
- Your firm failed to mark each sealed container with a code that identifies the establishment where packaged, the product contained therein, the year packed, the day packed, and the period during which packed as required by 21 CFR 113.60(c). Specifically, you only identify product with an expiration date; however, your product’s lot code does not include the (b)(4).
- Your firm’s operators of the retorts and persons who perform container closure examinations are not under the operating supervision of a person who has attended and successfully completed a thermal processing school approved by FDA, as required by 21 CFR 108.35(g).
- You must conduct or have conducted for 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 123.6(a) and (b). However your firm does not have a HACCP plan for canned tuna products to control the food safety hazard of scombrotoxin (histamine) formation.
We acknowledge that your firm receives certificates of histamine analysis from your tuna supplier; however, we recommend your firm conduct a hazard analysis to determine where the hazard of histamine formation is reasonably likely to occur such as receiving, any refrigerated cooler storage, thawing, and the pre-cooking processing steps. For additional information and guidance, please refer to Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. In addition, responding in English will help to assist us in our review of your documentation. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported low-acid canned 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 canned food regulations (21 CFR Part 108 and 113) is Import Alert #99-04. This alert can be found on FDA’s web site at: http://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, the low-acid canned food regulations (21 CFR Part 108 and 113), the Seafood HACCP regulations (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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Leslie Hintz, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Hintz at (240)402-2073 or via email at Leslie.Hintz@fda.hhs.gov.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition