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WARNING LETTER

Chongqing Tianrun Food Development Co., Ltd MARCS-CMS 686323 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Yu Liao
Recipient Title
General Manager
Chongqing Tianrun Food Development Co., Ltd

No. 99 Jiayuan Ave
Chongqing
Sichuan Sheng,
China

531683392@qq.com
Issuing Office:
Human Foods Program

United States

October 22, 2024

WARNING LETTER

Reference No. 686323

Dear Mr. Liao:

The United States (U.S.) Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) product facility, located at No. 99 Jiayuan Ave Chongqing, Sichaun Province, China from April 17 to April 19, 2024. During the inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation Part 113 (21 CFR 113). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at your firm.

As a manufacturer of LACF 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 Federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers. 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, including registration, and filing of process information, and the mandatory requirements in 21 CFR Parts 113. Regulations specific to the processing of LACF products are described in 21 CFR 108 and 21 CFR 113. As outlined in these regulations, a commercial processor that does not adhere to all the mandatory requirements of 21 CFR 108.35 and 21 CFR 113 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), 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 108.35 and 21 CFR 113 renders your 230g pouches of roasted gluten 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.

FDA received your written response, describing corrective actions taken and planned by your firm, on April 30, 2024. After reviewing the inspectional findings and responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We address your response below.

Emergency Permit Control regulation, (21 CFR 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR 113)

1. A commercial processor of thermally processed low-acid foods in hermetically sealed containers must register as a food canning establishment and file a form FDA 2541 (food canning establishment registration) with the FDA within 10 days after first engaging in the manufacture, processing, or packing, as required by 21 CFR 108.35(c)(1).

However, you did not register as a food canning establishment (FCE) before shipping your low-acid/ canned tofu products to the U.S., including seasoned tofu snack vacuum packaged (b)(4) inner bag. Your response stated you would work with a third-party to register your facility as an FCE. You submitted your FCE registration on May 30, 2024. However, based upon our records you exported low-acid canned tofu products to the United States multiple times between July 2023 and April 2024 before registering as an FCE.

2. A commercial processor engaged in the processing of acidified foods must file information regarding their scheduled processes with the FDA prior to the packing of a new product not later than 60 days after registration, as required by 21 CFR 108.35(c)(2). However, at the time of our inspection, you had not filed any scheduled processes for low-acid canned tofu products you ship to the U.S., including lot #(b)(4) TRAD of QQ Dried Beans utilizing a (b)(4) packaging size.

On June 12, 2024, you filed scheduled processes for QQ Dried Bean Curd (Spicy Flavor) (b)(4) (SID (b)(4)), Chongqing Style Dried Tofu (b)(4) (SID (b)(4)), Dried tofu with Mushroom (b)(4) (SID (b)(4)), and on July 22, 2024, you filed a scheduled process for Fried Tofu with Sauce (b)(4) (SID (b)(4)). A review of your filed scheduled processes found that you only uploaded heat distribution studies in “(b)(4)” and “(b)(4).” Furthermore, the container sizes listed in your filed scheduled processes do not appear to match the container packaging sizes of your LACF tofu products shipped to the U.S. reviewed during your inspection. In your response to this Warning Letter, you should describe which products are covered by your filed scheduled processes, including fill weight and container size. Furthermore, if you are processing products for the U.S. market in other retorts you should provide evidence that the filed critical parameters in each of your scheduled processes can be achieved when processed in any of your retorts.

3. Your firm did not provide evidence that the scheduled processes for the low-acid food products that you manufacture were established by a qualified person who has expert knowledge acquired through appropriate training and experience in thermal processing requirements for low-acid foods in hermetically sealed containers, as required by 21 CFR 113.83.

Specifically, you have (b)(4) still water immersion retorts which you use interchangeably for all low-acid canned tofu products shipped to the U.S.; identified as retorts (b)(4). During our inspection, our investigator reviewed all your available data from your process authority for your (b)(4) retorts and found that either you did not have any heat distribution data for a given retort or the process identified by the heat distribution data available was established for different container sizes and retort configurations. For example:

  • Retorts (b)(4) were installed in 2017, however, no heat distribution studies have been performed for retorts (b)(4).
  • Your process authority reported in your heat distribution studies for (b)(4) that higher temperatures are required during processing of (b)(4) packaging types, however, you have not implemented any process corrections to reflect this data and have made no adjustments to temperatures during routine processing of this package size.
  • No heat distribution testing for the (b)(4) packaging type has been conducted for retorts (b)(4). On April 8, 2024, you shipped QQ Dried Beans (b)(4) packaging size lot # (b)(4) TRAD to your trading company for export to the United processed in retorts (b)(4).
  • The heat distribution study for retorts (b)(4) were tested with a maximum of 5 kg of product per tray. However, you fill (b)(4) kg of product per tray for all retorts for the (b)(4) flexible packages. Your Production and Quality Managers stated your heat distribution study for retorts (b)(4) was performed for a different package type, which only fills 5 kg per tray.

In your translated response dated April 30, 2024, you committed to contacting a process authority to conduct thermal distribution studies on all retorts and heat penetration studies for all product packaging sizes and configurations. You also committed to registering as a FCE and filing scheduled processes established by your process authority with the FDA after completion. You did not provide any supporting documentation in your response to the FDA’s inspectional observations demonstrating that you had your process authority evaluate each product type, container size, and packaging configuration in all retorts being used to manufacture product to be shipped to the U.S. In your response to this letter, you should provide information identifying all products, fill weights, and container sizes shipped to the U.S. with corresponding filed scheduled process number (SID identifier); provide information documenting which retorts are being used for processing; and provide supporting documentation that each of your filed scheduled processes has been established by a competent process authority supported by temperature distribution and heat penetration studies in each applicable retort, as required by 21 CFR 113.83.

4. You did not measure and record critical factors specified in the scheduled process at intervals of sufficient frequency to ensure that the factors were within the limits specified in the scheduled process, as required by 21 CFR 113.40(b)(15).

Your firm processes LACF tofu products for the U.S. market in a horizontal water in still retorts. You have scheduled processes established by your process authority for the processing in these retorts, but you do not measure, nor maintain records of, the critical factors for the water immersion retort process including initial temperature (IT), fill weight, package thickness, processing temperature, processing time and processing pressure as critical for delivery of the scheduled process. Your retorts are not equipped with continuous temperature recording devices and no operator checks are made during the process. Furthermore, routine operator checks are not made during the process for processing pressure. All time, temperature and pressure entries are recorded to indicate the set point of the equipment program that is run, and do not reflect actual values checked by the operator.

Since you do not measure and record your critical parameters, you are unable to identify when your process deviates from the scheduled process, as required by 21 CFR 113.89. Our investigator reviewed your consumer complaints from 2023 until 2024 found at least (b)(4) consumer complaints indicating more than (b)(4) individual lots manufactured by your firm for various vacuum packaged products where customers have reported swollen vacuum packaged bags to your firm. There has been no contact with your process authority or review of your firm’s processing or handling procedures to investigate these lots or to determine the reason for the apparent under processing, which is also required by 21 CFR 113.89.

In your translated response dated April 30, 2024, you committed to purchasing an electronic temperature recorder to monitor the sterilization temperature every minute; add a process for monitoring the center temperature of the product before sterilization; strictly implement the critical parameters associated with each product; and maintain records. However, you did not provide any implementation records for your promised corrective actions to demonstrate that you are monitoring your critical process parameters established in your filed scheduled processes. Furthermore, you must also ensure that that when your critical parameters are not met that you evaluate these process deviations, as required by 21 CFR 113.89.

5. You must have a means to determine the water level in the retort during operation, e.g., by using a sensor, gage, water glass, or petcock(s) and record the water level at intervals sufficient to ensure its adequacy, as required by 21 CFR 113.40(b)(10). However, you do not check or record the water level during processing. Specifically, on April 18, 2024, our investigator observed a full retort cycle, and your operator did not observe or record the water level to ensure product was covered with water for the duration of the come-up time and sterilization cycle. Furthermore, during our investigator’s review of your horizontal water in still retort, he observed significant residue buildup in the water return lines on retort (b)(4) and an unknown object lodged in the water line on retort (b)(4). Your operators were unsure exactly how the retorts functioned and the potential impact of the observed conditions on operation of retort (b)(4) and retort (b)(4).

In your translated response dated April 30, 2024, you committed to add water inspection and sterilization inspection records, clean the water pipe wall regularly, and formulate a system for strict implementation. However, you did not provide any implementation records for the monitoring of the water level during retort operations. You also did not provide any supporting documentation to demonstrate you cleaned the water lines of retort (b)(4) and implement inspection of the water lines for all (b)(4) retorts.

6. You must have conduct appropriate detailed inspections and tests at intervals of sufficient frequency to ensure proper closing machine performance and consistently reliable hermetic seal production and maintain records of the tests, as required by 21 CFR 113.60(a)(3). However, you do not maintain records of the examination of the pouch container closures for your LACF tofu products shipped to the U.S. Specifically, you only perform hermetic seal adequacy checks at startup and do not record any hermetic seal checks at the packaging step. Our investigator reviewed your consumer complaints and observed multiple complaints of leaking bags and microbial contamination due to poor seals.

In your translated response dated April 30, 2024, you committed to modify your process to require that the packaging sealing of the product be tested every hour and record it. However, you did not provide any implementation records for this corrective action.

7. You must have plant personnel involved in thermal processing systems or other critical factors of the operation under the operating supervision of a person who has attended a school approved by FDA to comply with 21 CFR 113.10. Specifically, our inspection revealed no one at your firm has received training in critical factors in the production of LACF products nor aseptic processing.

In your translated response dated April 30, 2024, you committed to regularly conduct professional knowledge training for sterilization operators and keep records. You did not provide records demonstrating this training had been scheduled or completed. You did not provide any information regarding the qualifications of the trainer or that the training corresponds to a course of instruction approved by the Commissioner of the U.S. Food and Drug Administration to meet the requirements of 21 21 CFR 108.35(g),

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, 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 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 acidified 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, examples of Import Alerts that convey information specific to foreign firms that are not in compliance with the acidified food regulations (21 CFR 108 and 114) are Import Alert 99-37, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods without Filed Scheduled Processes and Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control. These alerts can be found on FDA’s web site 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 all processing plants you operate are in compliance with the Act and all applicable FDA regulations, including the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply via email to Victoria.Wagoner@fda.hhs.gov or to the Food and Drug Administration, Attention: Victoria Wagoner, Compliance Officer, Office of Compliance and Enforcement, Office of Enforcement, Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. Please reference 686323 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Maria S. Knirk, J.D.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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