Inspections, Compliance, Enforcement, and Criminal Investigations
Dong-A Otsuka Co. Ltd. 12/2/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD
DEC 02 2010
VIA OVERNIGHT MAIL
Mr. Jung Suk Kang
Dong-A Otsuka Co., Ltd.
Reference No.: 143253
Dear Mr. Kang:
The U.S. Food and Drug Administration (FDA) inspected your acidified food facility (Chilseo Factory) located at 282-3, Daechi-Li, Chilseo-Myoun, Haman-Gun, Kyoung Sang Nam-Do, Korea on August 19-20, 2010. During that inspection, we found that your firm had serious deviations from the acidified food regulations (21 CFR Parts 108 and 114). Failure to comply with all of the mandatory requirements of 21 CFR 108.25 and 21 CFR Part 114 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 108.25(j) for products offered for entry into the United States. In addition, such failure renders your acidified 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, “Pocari Sweat”, 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 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, listing the deviations found at your firm at the conclusion of the inspection. Your firm’s September 29, 2010 response to the FDA-483 did not adequately address these deviations. Therefore, we have the following concerns with regard to your acidified food products:
• Your firm failed to provide FDA’s Center for Food Safety and Applied Nutrition (CFSAN) within 60 days after registration, and before packing any new product, information on the scheduled processes including as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process for each acidified food in each container size as required by 21 CFR 108.25(c)(2). Specifically, your firm’s Chilseo Factory (FCE #15288) does not have filed scheduled processes for the acidified non-carbonated beverage drinks you manufacture and distribute to the U.S. On August 20, 2010, your firm provided our investigator with a copy of SID 2010-04-01/001 from your Anyang Factory in Kyungki-Do, Korea (FCE #15282) as basis for the Pocari Sweat product your firm manufactured at the Chilseo Factory that day. Scheduled processes must be filed for each specific product at each specific processing location, and your firm’s September 29, 2010 response did not include a corrective action for this deviation.
• Your firm’s plant personnel involved in acidification, pH control, heat treatment, or other critical factors of the operation are not under the operating supervision of a person who has attended a school approved by FDA, as required by 21 CFR 108.25(f). Specifically, no one at your beverage manufacturing factory has received training in pH controls and critical factors in acidification. Your firm’s September 29, 2010 response states that your facility has received certifications from ISO 22000, the UK Accreditation Service, British Standard Institution, and Hygiene Evaluation from the Korean Food & Drug Administration; however, it is not clear that these certifications include pertinent acidified food processing principles such as acidification, pH control, and heat treatment.
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. 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 R. 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 firstname.lastname@example.org.
Office of Compliance
Center for Food Safety
and Applied Nutrition
Mr. Woong-Seob Oh
Dong-A Otsuka Co., Ltd. (Chilseo Factory)
Kyoung Sang Nam-Do