Inspections, Compliance, Enforcement, and Criminal Investigations
Sanuki Kanzume Co 3/29/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD
MAR 29 2011
VIA OVERNIGHT MAIL
Mr. Suga Wara Toshiuk
Head of the Factory
Sanuki Kanzume Co.
Reference No.: 166492
Dear Mr. Toshiuk:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food facility located at 123 Kamiohno, Yurijhonjyo-shi, Japan on November 18-19, 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 108.25(j) 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. Your firm’s November 30, 2010 response to the FDA-483 did not adequately address all of these deviations. We have the following remaining concerns with regard to your low-acid canned food products:
• Your firm failed to obtain substantiation by a qualified scientific authority as to the adequacy of any intentional change in a previously filed scheduled process as required by 21 CFR 108.35(c)(2)(ii). Specifically, your firm’s filed scheduled process for “Mushrooms Nameko (Whole) in Water Salt Added: Nameko Mizuni” (b)(4) size cans. You are currently processing (b)(4) which are not listed as an optional can size in your current process filing. You stated in your response that you will submit a revised process filing according to new heat penetration tests for this size can, but at this time, this revised process filing has not been received by FDA. In addition, your revised process filing for this product should include venting times and temperatures which are critical factors for still retorts and must be recorded as required by 21 CFR 114.100(a)(1).
• Your firm failed to determine and record the initial temperature of the contents of the containers to be retorted to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process as required by 21 CFR 113.87(c). Specifically, you do not measure the initial temperatures of your 301 x 407 cans of Nameko Mizuni mushrooms. Your response indicates that you will monitor the initial temperature of the containers, but you did not provide any processing records as written documentation to demonstrate your firm’s implementation of this new procedure.
• Your firm’s vertical still retorts failed to be equipped with a 1/16” or larger bleeder installed either within the retort shell or in a well attached to the shell as required by 21 CFR 113.40(a)(2). Your response indicates that you installed a 1/16” bleeder on November 26, 2010, but did provide any photo evidence to support this corrective action.
• Your firm failed to perform and record teardown examinations for double-seam cans enough containers from each seaming station to ensure maintenance of seam integrity as required by 21 CFR 113.60(a)(2). Specifically, your firm has a (b)(4). Your firm’s can seam teardown examination records show only one can from a single closing machine head examined during the can seam teardown examination. Your response indicates that you will conduct teardown examinations of the double seam using one can from each seaming head and will record the results on your can seam teardown form, but you did not provide any copies of completed can seam teardown records as documented evidence.
• Your firm failed to chlorinate as necessary the container cooling water used in your cooling canals and recirculated water supplies as required by 21 CFR 113.60(b). Specifically, there were no records of chlorine content for the cooling water in your firm’s retort crate/can cooling tank and no detectable chlorine was found in the cooling tank when the chlorine level was measured on November 18, 2010. Your response indicates that you will measure the chlorine content prior to the usage of the cooling tank, but you did not provide any copies of completed records as documented evidence.
In addition, your firm’s filed scheduled process for “Japanese Mushrooms (Whole) in Water” (b)(4) lists “Still Horizontal” for its retort processing method. Your firm informed our investigator that your firm never owned or (b)(4) in your facility and that your process authority used their (b)(4) to run the heat distribution study for this product. Therefore, your firm needs to revise this process filing based on a new heat distribution study conducted on your firm’s own (b)(4).
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 email@example.com.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition