| Public Health Service Food and Drug Administration |
| College Park, MD |
Department of Health and Human ServicesWARNING LETTER
VIA OVERNIGHT MAIL
Mr. Zhang Longfu, President
5 Latitude Four Road
Liujing Industrial Park, Liujing
Hengxian County
China
Reference No.: 167295
Dear Mr. Longfu:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food facility located at 5 Latitude Four Road, Liujing Industrial Park, Liujing, Hengxian County, China on January 17-21, 2011. 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 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. We have the following concerns with regard to your low-acid canned food products:
- Your firm failed to have heat distribution data on file which demonstrates that adequate venting of air is accomplished, as required by 21 CFR 113.40(a)(12)(iii). Specifically, according to your processing records for canned mushrooms, your firm frequently vents three retorts at the same time. However, the heat distribution data on file at your facility indicates that you should avoid venting more than (b)(4) at the same time due to the size of your main steam line. On at least three occasions your venting records indicate that you vented (b)(4) at the same time, contrary to the recommendation of your process authority. Although you spoke with your process authority regarding the three simultaneous venting instances discovered during our inspection and indicated that the products were considered safe, we continue to have concerns regarding your practice of venting more than (b)(4).
- Your firm failed to record required information on designated forms at the time the observation was made by the retort or processing operator or designated person, as required by 21 CFR 113.100(a). Specifically, your firm indicated that not all data is entered on records at the time the observation or test results are known. Of particular concern, our investigators discovered multiple records entitled “Production Workshop Clock Calibration Record” dated October 26, 2008 with different results for clock calibration. In addition, our investigators also observed instances where blank QC records contained the signature of a supervisor signifying the records had been reviewed for completeness and accuracy.
- Your firm failed to mark each hermetically sealed container of low-acid processed food with an identifying code that is permanently visible to the naked eye, as required by 21 CFR 113.60(c). Specifically, (b)(4) of canned pieces and stems mushrooms (215x400 size cans) processed on January 9, 2011, were being stored in your warehouse unlabeled and uncoded. In addition, (b)(4) of canned whole button mushrooms (211x211 size cans) were also being stored in your warehouse, some of which were unlabeled and uncoded.
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: Brandon Bridgman, 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. Bridgman at (301) 436-2073 or via email at Brandon.Bridgman@fda.hhs.gov.
Sincerely,
/S/
William A. Correll
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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