| Public Health Service Food and Drug Administration |
College Park, MD |
Department of Health and Human ServicesWARNING LETTER
DEC 2, 2010
VIA OVERNIGHT MAIL
Mr. P. Y. Ling
General Manager
United Taiwan Corporation
5/6Fl, 22 Jen-Ai Rd. Section 1
Taipei, Taiwan ROC
Reference No.: 140750
Dear Mr. Ling:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) facility, Chao Zhou Plant, located at 255 JieShow Road, Chao Zhou, Taiwan, on August 5-6, 2010. 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 LACF 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, Sweet Red Beans, 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.
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 provided a response to the FDA-483 via e-mail on August 16, 2010, and adequately addressed the Current Good Manufacturing Practice deviations. However, upon further review of the inspectional findings and documentation provided in your firm’s responses, we have the following concerns with regard to your LACF products:
Your firm failed to identify when any process was less than the scheduled process and when critical factors were out of control for your low-acid canned food product as required by 21 CFR 113.89:
• Your firm’s filed scheduled process for Sweet Red Beans (b)(4) lists a (b)(4) as a critical factor for your (b)(4) retort. On 08/06/2010, a review of retort processing records [02/05/2008, 08/21/2008, 11/10/2008, 05/14/2009, 11/21/2009, and 12/18/2009] revealed that the retort rotation was recorded as (b)(4) during the processing of Sweet Red Beans. Although your firm reviewed these records, your firm did not identify these process deviations, and therefore, did not take any corrective actions or further evaluate the process and the finished product.
Your August 16, 2010 response states that the (b)(4) on your retort uses a computer program that can only set the (b)(4) however, the actual retort is set as (b)(4). You also explain that your heat penetration tests (dated 06/10/1993) indicate that the (b)(4) and that your retort operator deems an (b)(4) is the normal range and that no corrective action is necessary. FDA has determined that this response is inadequate based on the fact your filed scheduled process lists a (b)(4) as a critical factor that must be adhered to in accordance with 21 CFR 108.35(c)(3)(i). If your firm has studies which demonstrate a full thermal process cook at a slower agitation speed, we recommend that you amend your current scheduled process on file to account for the change in your processing parameters.
• Your firm’s filed scheduled process for Sweet Red Beans (b)(4) lists a critical process temperature of (b)(4) On 08/06/2010, a review of the retort temperature recording chart for product processed on 02/15/2008 indicated that the temperature for Batch #1 (b)(4). Although your firm reviewed this record, your firm did not identify this process deviation, and therefore, did not take a corrective action or further evaluate the process and the finished product.
Your August 16, 2010 response states that according to your SOP, the retort operator shall extend sterilization time as indicated on the SOP Time Extension Chart if the processing temperature (b)(4). You explain that since the temperature (b)(4) the retort operator did not identify this temperature (b)(4) as a process deviation, and therefore no corrective action was taken. You also say that you will revise your SOP to comply with FDA regulations, but you do not provide an explanation as to what additional corrective actions you will take. FDA has determined that your response is insufficient and that further explanation is necessary to determine compliance.
In addition, after further review of your filed scheduled process for Sweet Red Beans (b)(4) we determined that the parameters listed do not match those typically filed for (b)(4). You should file a revised scheduled process filing needs electronically by using your online access to FDA/CFSAN’s LACF Online Database. The new process filing for this product should include appropriate critical factors pertinent to end-over-end agitation processing in water as determined by your process authority.
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 your 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 robyn.jones@fda.hhs.gov.
Sincerely,
/s/
Joann Givens
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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