| Public Health Service Food and Drug Administration |
| College Park, MD |
Department of Health and Human Services
WARNING LETTER
April 28, 2011
VIA OVERNIGHT MAIL
Mr. Visut Limlurcha, Managing Director
Great Oriental Food Products Co., Ltd.
300 Taar Sai-Luad
Mae Sod, Tak 63110
Thailand
Reference No.: 181732
Dear Mr. Limlurcha:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food facility located at 300 Taar Sai-Luad, Mae Sod, Tak, 63110, Thailand on January 20-21, 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 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 canned food 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 can find the Act and the acidified food regulations through links in FDA’s home page at http://www.fda.gov.
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. We have the following concerns with regard to your low-acid canned food products:
- Your firm made an intentional change in a previously filed scheduled process; however, you failed to submit to FDA, within 30 days after first use, a complete description of the modifications made and utilized, as required by 21 CFR 108.35(c)(2)(ii). Specifically, based on recommendations from your process authority, your firm has implemented modifications to your scheduled process for “Baby Corn (Whole Spear, Cut, Broken, Free Count) In Brine” (b)(4); however, you failed to file your updated scheduled process with FDA within 30 days after first use.
- 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 a process with FDA for your “Baby Corn (Whole Spear, Cut, Broken, Free Count) In Brine” (b)(4); however, during our inspection you were processing the baby corn in brine product using a different scheduled process than the one filed with FDA.
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. For instance, your response should include a copy of the heat distribution study conducted on your current “Baby Corn (Whole Spear, Cut, Broken, Free Count) in Brine” process. 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 you firm operates in compliance with the Act, the low-acid canned food regulations (21 CFR Part 108 and 113), and the Current Good Manufacturing Practice regulation (21 CFR Part 110), and other applicable regulations. 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: Robyn Jones, 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. Jones at (301) 436-2575 or via email at Robyn.Jones@fda.hhs.gov.
Sincerely,
/S/
William A. Correll
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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