WARNING LETTER
Fuyang Fuchunjiang Canned Food Co., Ltd.
MARCS-CMS 682507 —
May 31, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jian Liang Wang
Recipient Title
General Manager
Fuyang Fuchunjiang Canned Food Co., Ltd.
241-1 Xiyou Village, Fuchan Street
Fuyang Shi
Hangzhou Shi
Zhejiang Sheng
,
311403
China
jianliangwang19@sina.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
May 31,2024
WARNING LETTER
Reference # 682507
Dear Mr. Jian Liang Wang:
The United States (U.S.) Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) product facility, located at 241-1 Xiyou Village, Fuchan Street, Fuyang District Hangzhou, Zhejiang, 311403 China from March 11 to March 13, 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 March 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. You must process each low-acid canned food in conformity with at least the scheduled process, as required by 21 CFR 108.35(c)(3)(i). Specifically, your heat distribution study, “HD for Heat Horizontal Still Water Spray Retort
(b)(4)
” dated August 28, 2023, and your heat penetration study for 230g roasted gluten” dated September 20, 2019, which your firm relies on to support your filed scheduled process for 230g roasted gluten, identifies the retort basket loading pattern and container position in the retort as critical factors. The 2019 heat penetration study identified that “all bags were stacked jumbled in the basket (Monolayer not Superimposed).” The 2023 heat distribution study identified the stacking configuration of 4 groups bracket /retort, 6 baskets / bracket.” However, the total number of pouches per retort cycle was not recorded in either study. You were not actively processing 230g roasted gluten during the inspection, but after interviewing your retort operator, production manager, and Process Authority (PA), it was determined that
(b)(4)
/230g pouches would be the maximum number of pouches per basket while maintaining a monolayer of the solids in each pouch. Based upon a single layer of 63 pouches per basket, the maximum number of pouches per retort cycle should not exceed 1,512/230g pouches. However, during the investigator’s batch record review,
(b)(4)
batches of roasted gluten 230g were identified where
(b)(4)
/230g pouches were processed in a single retort cycle, which may have led to those batches exported to the U.S. being under-processed.
Your response stated your PA conducted a heat distribution study for Horizontal Still Water Spray Retort
(b)(4)
and heat penetration study for 230g roasted gluten on March 28 and March 29, 2024. The test was conducted with a specific retort basket loading pattern of
(b)(4)
baskets, with each basket having
(b)(4)
trays, and
(b)(4)
pouches in each tray (
(b)(4)
layers, cross stack), totaling
(b)(4)
/230g pouches for a single retort cycle. Your PA concluded a uniform temperature distribution was achieved in Horizontal Still Water Spray Retort
(b)(4)
with
(b)(4)
/230g pouches per retort cycle. You filed a new scheduled process on March 29, 2024, to reflect this change in retort loading pattern. The adequacy of this corrective action will be verified during a future inspection.
2. You did not ensure your
(b)(4)
processing system, horizontal still water spray retort, was operated in a manner to ensure commercial sterility was achieved, as critical parameters were not measured and recorded at intervals of sufficient frequency to ensure they were within the limits specified in the scheduled process(es) for your low-acid canned foods as required by 21 CFR 113.40(j). Specifically, your horizontal still water spray retort used to process 230g pouches of roasted gluten product did not have a flow meter nor a temperature recording device installed.
a. Your scheduled process for 230g pouches of roasted gluten identifies the critical factor minimum water flow rate of
(b)(4)
gallons per minute (gpm). Although, you had installed a
(b)(4)
pump on the retort, you were not able to measure the critical factor of water flow rate to ensure the appropriate processing conditions were achieved nor did you have records that the pump delivered a water flow of
(b)(4)
gpm. You told our investigator that you had never checked the water flow rate since the horizontal water spray retort was installed in 2019 for batches of roasted gluten exported to the U.S.
b. Your scheduled process for 230g pouches of roasted gluten identifies the critical factor minimum and a minimum processing time of 54 minutes at processing temperature 243°F (when the initial temperature is 59°F). You did not install a temperature recording device (TRD) on your horizontal still water spray retort until November 26, 2023. Moreover, after you installed the TRD you did not generate and maintain continuous temperature recording chart data for batches of roasted gluten 230g exported to the U.S., instead you only documented the processing temperature once per batch. This temperature data is critical to ensure the
(b)(4)
process has achieved a commercially sterile product.
Your response stated you added a water flow rate meter onto the
(b)(4)
pump of the Horizontal still water spray retort
(b)(4)
with a measurement range of
(b)(4)
on March 26, 2024. The meter was calibrated, and the minimum flow rate was set to
(b)(4)
m3/h (
(b)(4)
gallons/min). The new flow rate was used during the studies carried out by your PA on March 28 and March 29, 2024. You also created a new record ‘water flow rate record’ to document the water flow rate every 10 minutes and provided completed records for two batches manufactured on March 30, 2024.
Your response also
(b)(4)
. Your retort operator was trained on March 28, 2024, and you provided a completed TRD chart for
(b)(4)
batches of finished product manufactured on March 30, 2024.
The adequacy of your corrective actions will be verified during a future inspection. However, you did not provide any supporting evidence or an evaluation by your PA to address the products still on the market in the U.S. were manufactured in accordance with their scheduled process and safe for consumption. In your response, to this Warning Letter you should evaluate all lots of roasted gluten 230g within shelf-life in the U.S. manufactured prior to March 30, 2024, to ensure they are commercially sterile. Please let us know if you intend to take any market action against this product.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter.
Failure to adequately address these violations may lead to regulatory action. For instance, we may take further action to refuse admission of your imported snack 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 LACF food regulations (21 CFR 108 and 113) is 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 web site at: www.accessdata.fda.gov/cms_ia/ialist.html.
We also offer the following comment:
21 CFR Part 113.60(a)(2) states that for closures other than double seams and glass containers, appropriate detailed inspections and tests shall be conducted at intervals of sufficient frequency to ensure proper closing machine performance and consistently reliable hermetic seal production. You stated you rely on visual examination of the packages as they move through processing to ensure container integrity, but you do not document the number of discarded packages. In addition, your laboratory conducts additional tests approximately every
(b)(4)
hours on
(b)(4)
pouches, including a pressure test and a manual hand pull seam test. Your Quality Control Manager stated poorly seamed bags do not usually trigger an investigation and are discarded. We note you have received complaints of damaged seams in product shipped to the U.S. You should track the number of discarded packaged to assist in ensuring a reliable hermetic seal. Furthermore, our investigator noted that you do not perform any type of destructive test on your PE laminated foil pouches used to packaged roasted gluten for the U.S. market. For physical testing of the reliability of the hermetic seal the regulation does not specify test methods or frequency of testing for pouches. However, we would recommend such testing be conducted.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response to this letter should outline the specific steps you are taking or have taken to correct these deviations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If your firm’s planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.
You should direct your written reply to Victoria Wagoner, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-607), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Wagoner via email at Victoria.Wagoner@fda.hhs.gov. Please reference #682507 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
Ann M. Oxenham, J.D.
Director, Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/09/2024
Regulated Product(s)
Food & Beverages