DEPARTMENT OF HEALTH & HUMAN SERVICES
June 20, 2012
Mrs. Mala Muangkleing, Director
The Fruitory (Thailand) Co., Ltd.
41/9 Moo 5 Tambol Bangyai
Reference No.: 317179
Dear Mrs. Muangkleing:
We inspected your processing facility, The Fruitory (Thailand) Co., Ltd., located at 41/9 M. 5 Tambol Bangyai, Bangyai, Nonthaburi, Thailand on February 20, 2012. We found that you had significant deviations from the current Good Manufacturing Practices (cGMP) regulations for food manufacturers (Title 21, Code of Federal Regulations (CFR), Part 110) and that your food facility was not registered. At the conclusion of the inspection, our investigator issued an FDA Form 483 listing observations of concern. Those violations cause the dried fruit, dried mung beans and chilies manufactured at your facility to be 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)] in that it was prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in § 415 of the Federal Food, Drug and Cosmetic Act (the Act), (21 U.S.C. § 350d) and our implementing regulations at 21 CFR Part 1, Subpart H. During the inspection of your facility, you were advised of this requirement. The failure to register a facility as required is a prohibited act under § 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that, to date, this facility has not been registered with FDA. You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
We note the following sanitation deviations that need correction:
Your employees do not wash and sanitize hands thoroughly in an adequate hand washing facility before starting work, after each absence from the work station, and at any time their hands may have become soiled or contaminated to comply with 21 CFR 100.10(b)(3). Specifically, the employee demonstrating hand washing outside at the restroom sink did not use soap or dry his hands. He had not been trained in proper hand washing techniques.
You do not provide employees with readily accessible and adequate toilet facilities to comply with 21 CFR 110.37(d). Specifically, your restroom lacked toilet paper.
You do not have sanitary towel service or suitable hand drying devices to comply with 21 CFR 110.37(e)(3). Specifically, no single use hand towels or drying device was available to dry hands after using the toilet and before starting work.
- Your facility does not have posted, readily understandable signs directing employees to wash and sanitize hands as appropriate to comply with 21 CFR 110.37(e)(5). Specifically, you do not have signage instructing employees to wash their hands after using the toilet and before work.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator or agent in charge of this facility, or an individual authorized by the facility’s owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA’s food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
Food Facility Registration
5100 Paint Branch Parkway
College Park, MD 20993
When completed, the form may be faxed to (301) 436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility’s registration number using the same method used to submit the registration to FDA.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. It is your responsibility to assure that your processing plant operates in compliance with applicable laws and regulations enforced by the FDA. Please respond within thirty (30) days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation or other useful information that will assist us in evaluating your corrections. If you cannot complete all corrections before you respond, including registering your food facility, you should explain the reason for your delay and state when you will correct any remaining violations and comply with the registration requirement.
Please send your reply to the Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have nay questions regarding the above violations, you may contact Ms. Purnell by phone at (240) 402-1613 or via email at email@example.com.
If you have any questions about registering your facility, please call this office the FURLS Helpdesk at 800-216-7331 or via email at firstname.lastname@example.org.
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition