Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guilin-sanyang-dietary-ecological-industry-coltd-598109-02062020
Timestamp: 2020-07-03 13:45:35
Document Index: 196088390

Matched Legal Cases: ['art 108', 'art 113', 'art 114', '§ 344', 'art 113', 'art 114', 'art 108', 'art 113', 'art 114', 'art 108', 'art 108', 'art 113', 'art 114', '§ 344', '§ 381', 'art 108', 'art 113', 'art 108', 'art 114', '§ 342', '§ 381', 'art 108', 'art 113', 'art 114', 'art 108', 'art 113', 'art 114', 'art 117']

GuiLin SanYang Dietary Ecological Industry Co.Ltd. - 598109 - 02/06/2020 | FDA
GuiLin SanYang Dietary Ecological Industry Co.Ltd. - 598109 - 02/06/2020
GuiLin SanYang Dietary Ecological Industry Co.Ltd. MARCS-CMS 598109 — February 06, 2020
Mr. Qin Hui Yue
GuiLin SanYang Dietary Ecological Industry Co.Ltd.
No. 13 Xicheng South
Lingui Qu
Guangxi Zhuangzuzizhiqu, 541100
Reference No. 598109
Dear Mr. Qin Hui Yue:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned food and acidified food facility located at No.13 Xicheng Boulevard Lingui District, Guilin, Guangxi China on September 24, 2019. During our inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation [Title 21, Code of Federal Regulations (21 CFR Part 108)], Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR Part 113) and the Acidified Food regulation (21 CFR Part 114). At the conclusion of the inspection, FDA investigators issued your facility an FDA Form-483 (FDA-483), lnspectional Observations, listing the violations found at your firm. We acknowledge your firm's written response to the FDA-483, received on October 9, 2019, which included a description of corrective actions taken by your firm. Our review of your response determined that your firm has not adequately addressed all the violations related to your low-acid canned food (LACF) and acidified food (AF) products.
As a manufacturer of LACF and AF products intended for export to the United States, you are required to comply with the Federal Food Drug and Cosmetic Act (the Act) and the regulations promulgated under the Act, including those relating to the processing of low-acid foods packaged in hermetically sealed containers and acidified food products. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 CFR 108.35 and 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 113 and 21 CFR Part 114. Regulations specific to the processing of LACF products are described in 21 CFR Part 108, 21 CFR Part 113 and 21 CFR Part 114.
As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR Part 108.35, 21 CFR Part 108.25, 21 CFR Part 113, and 21 CFR Part 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. § 344). As stated in 21 CFR 108.35(k) and 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. § 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR Part 108.35 and 21 CFR Part 113, and 21 CFR Part 108.25 and 21 CFR Part 114 renders your low acid and acidified products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You can find the Act and LACF regulations through links in FDA's home page at www.fda.gov.
We note the significant violations as follows:
1. Your firm did not have an accurate temperature-recording device on (b)(4) retort #2, as required by 21 CFR 113.400). Specifically, you informed us during the inspection that (b)(4) manufactured in your (b)(4) retort. Critical factors such as processing temperatures must be measured and recorded at intervals of sufficient frequency to ensure that critical factors are within the limits specified in the scheduled process.
Your October 9, 2019, response indicated that sterilization technicians have been trained to download and print data; however, you provided a blank training check-in form. We are unable to evaluate the adequacy of your response because you did not provide documentation demonstrating that your temperature recording chart from your (b)(4) retort #2 is operative nor did you provide any supporting records for the LACF rice noodles processed during the time your temperature recording device was inoperable.
2. Your firm does not examine pouch container closures in appropriate detail for your LACF rice noodle pouches to ensure proper closing machine performance and consistently reliable hermetic seal production, as required by 21 CFR 113.60(a)(3). Specifically, on September 24, 2019, we observed (b)(4) vacuum test conducted on (b)(4) rice noodle pouch, which you stated is tested (b)(4) times per day. This frequency interval is not sufficient to ensure proper closing machine performance and consistently reliable hermetic seal production on your LACF rice noodle pouches. Additionally, you did not have any records documenting any container integrity tests.
Your October 9, 2019, response included your "(b)(4)" Inspection Control Procedure, dated September 29, 2019 and a blank template record. However, we are unable to evaluate the adequacy of your response because you did not provide documentation to show that you are implementing the container integrity testing per the frequency described in your procedure.
3. Your firm's process and production information forms did not include the information required by 21 CFR 113.100(a). Specifically, your record for LACF rice noodles, dated August 15, 2019, did not include the following information: (b)(4).
Your October 9, 2019, response provided a revised blank sterilization template record which does not include flow rate or minimum come-up time, which are both identified as critical factors in your scheduled process. Further, you did not include supporting documentation, including completed production records, to show that you are implementing the revised record.
4. Your firm did not maintain processing and production records showing adherence to the scheduled process, as required by 21 CFR 114.100(b). Specifically, you did not maintain any (b)(4) testing records for any batches of acidified vegetables, used as a component of rice noodle packets. Additionally, on September 24, 2019, we observed that your laboratory manager was not able to perform a calibration of the (b)(4) meter and could not perform a (b)(4) test upon request.
Your October 9, 2019, response included a procedure on how the (b)(4) meter is calibrated and operated. Additionally, you indicated that training was provided to the laboratory technician. However, we are unable to evaluate the adequacy of your response because you did not include supporting documentation of (b)(4) testing records to ensure your firm is adhering to the filed scheduled process for acidified vegetables, where (b)(4) is identified as a critical factor.
5. Your firm did not mark each container with an identifying code, as required by 21 CFR 114.80(b). Specifically, your (b)(4) Rice Noodle packets contain separate components, including both LACF and AF products. For your acidified components (pickled cabbage, pickled cow peas, and pickled bamboo shoots), you did not have a code applied to each container.
Your October 9, 2019 response included a "(b)(4)" dated October 7, 2019. Your procedure lists that the "(b)(4)" and the code composition described in the procedure lists "(b)(4)." You did not include a code for the establishment where the product was packed, nor did you provide any supporting evidence that each of these acidified components has this coding listed on the outer packaging.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, including processing records for (b)(4) lots of product produced over at least (b)(4) days. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. Responding in English will help to assist us in our review of your documentation. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported LACF and/or AF 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 LACF and AF regulations (21 CFR Part 108, Part 113 and/or Part 114) are Import Alert #99-38, "Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control". This alert can be found on FDA's website at: www.accessdata.fda.gov/cms_ia/ialist.html.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the Low Acid Canned Food and Acidified regulations (21 CFR Part 108, Part 113, and Part 114), and the current Good Manufacturing Practices regulation (21 CFR Part 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
• We note, on September 24, 2019, you limited access to what FDA Investigators were able to observe within the retort (b)(4) areas of your facility and refused Investigators' from taking photographs within this retort (b)(4) area. As a foreign food manufacturer exporting product to the United States, we remind you that FDA can inspect the facility at the time and in the manner, as permitted by the Food, Drug, and Cosmetic Act. Additionally, by submitting your Food Facility Registration with FDA, you acknowledge and permit FDA to conduct inspections, as described above. Foreign factories, warehouses, or other establishments who refuse to permit entry of United States inspectors or other individuals, duly designated by the Secretary, to inspect their factories, warehouses, or other establishments can be listed, for example, on the Red List of this Import Alert #99-32, food products from those facilities are subject to refusal of admission as set forth in section 807 of the FD&C Act.
• We encourage your firm to conduct a comprehensive review of all your filed processes and continue to work with your process authority to ensure that the information included in each filed process, including supporting documentation, is accurate and reflects your current plant operations. For example, on September 24, 2019, we observed that the (b)(4) rice noodle pouches are not the actual size used in production. Specifically, your (b)(4) rice noodle pouch was measured at (b)(4) mm ((b)(4) in); however, your filed process (SID (b)(4)) lists (b)(4) mm ((b)(4) in). Additionally, we observed that (b)(4)((b)(4)) pouches were added per retort load; however, per your (b)(4) study, dated May 13, 2018, states that the maximum number of containers per load is (b)(4) pouches.
Please send your reply to the Food and Drug Administration, Attention: Lisa Thursam, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Lisa Thursam at lisa.thursam@fda.hhs.gov. Please reference #598109 on any submissions and within the subject line of any emails to us.