Inspections, Compliance, Enforcement, and Criminal Investigations
Lactasoy Company Limited
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|College Park, MD 20740|
APR 15 2010
Ms. Wattanamart 'Kelly' Pantang
International Trade Key Account Manager
Lactasoy Company, Ltd.
3532 Sukhumvit Rd
Bangkok, Thailand 10250
Dear Ms. Pantang:
Food and Drug Administration (FDA) inspected your low-acid canned food facility located at 199 Moo 10 Chacherngsao-Kabinburi Rd, Srimahaphaot District, Prachinburi, Thailand 25140 on November 3-4, 2009. 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, soymilk in glass bottles, 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.
Your significant violations were as follows:
o Your (b)(4) retort did not have an accurate temperature recording device as required by 21 CFR 113.40 (D(2). Specifically, the temperature recorder strip charts were not marked to indicate the dates covered or the section of the retort they represented. Also they did not have any markings as to the meaning of the vertical scale in terms of temperature or the horizontal scale in terms of time; and they did not have any signatures or initials of retort operator and record reviewer.
o A system for product traffic control in the retort room was not established in accordance with 21 CFR 113.87(b) to prevent un-retorted product from by-passing the retort process. Specifically, heat-sensitive indicators or other means are not used to visually show that a thermal process has been applied to containers.
o Cold water vacuum was not measured in accordance with 21 CFR 113.60(a)(2) for glass containers with vacuum closures. Specifically, vacuum tests were not performed on the glass container capper to measure the cold water vacuum before actual filling operations.
o Your firm did not provide information as to the scheduled processes including all critical control factors affecting heat penetration in accordance with 21 CFR 108.35(c)(2) for
soymilk in glass containers processed in your (b)(4) retort. Specifically, your process filing for soymilk in (b)(4) does not include minimum times and temperatures for the retort cooling legs for which your process credits; or minimum times and temperatures for any of the heating legs for which your process credits.
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 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 your processing plant 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). 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: Donald W Greaves, 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 Mr. Greaves at (301) 436-2057 or via email at email@example.com.
Office of Compliance
Center for Food Safety
and Applied Nutrition