- Did not process a food in conformity with at least the scheduled process filed with FDA as required by 21 CFR 108.35 including: products produced in 2023 were processed at a different time and temperature than the scheduled process filed with the FDA
- The heat distribution study does not adequately support the scheduled process filed with the FDA.
- The firm’s retorts did not have an accurate temperature-recording device as required by 21 CFR 113.40(b)(2)
- The processing and production records for products failed to document the specific product variety, approximate number of containers per coding interval, initial product temperature, temperature-indicating device readings, and temperature recording device readings. Additionally, as these USA products are produced in a horizontal still water (b)(4) retort, the firm failed to document time steam on, time temperature up to processing temperature, time steam off, and venting time and temperature to which vented. The abovementioned data is also not documented or recorded on processing and production records for any of the LACF products the firm produces for the USA market.
- The firm did not use or document any form of heat-sensitive indicators or other effective means to ensure the baskets have been processed in the horizontal still water (b)(4) retorts used to process the USA low-acid canned food products.
- The firm’s only printed identification code for USA hermetically sealed pouches consists of a 10-month best by date, which does not adequately identify the establishment where packed, the product in the container, year packed, day packed, or period during which packed
- The firm did not reference (b)(4) thermometer to document the retort processing temperature. By the admission of your Equipment & Maintenance Manager, the firm relies on the (b)(4) digital temperature control probe display to document the processing temperatures on the horizontal still water (b)(4) retorts ((b)(4)) used to process LACF products for the USA market.
- The General Manager, Assistant Quality Control Manager, and the Equipment & Maintenance Manager, and none of the processing system or retort operators have ever attended training for thermally processing low-acid canned foods, such as a Better Process Control School, nor are they under the supervision of anyone who has completed such training.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hunan-gagazui-food-co-ltd-673799-02092024
Hunan Gagazui Food Co., Ltd.
MARCS-CMS 673799 — FEBRUARY 09, 2024
Hunan Gagazui Food Co., Ltd.
MARCS-CMS 673799 — FEBRUARY 09, 2024
Recipient:
Ms. Xia Wang
Owner
Hunan Gagazui Food Co., Ltd.
Sanfeng Industrial Park
Huarong Xian Yueyang Shi Hunan Sheng, 414200
China
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
February 9, 2024
WARNING LETTER
Reference # 673799
Dear Ms. Xia Wang:
The U.S. Food and Drug Administration (FDA) inspected your low acid canned food (LACF) facility, located at Sanfeng Industrial Park, Huarong County, Yueyang, Hunan, 414200, China, on November 20 through 23, 2023. During that 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 Part 108), the Low Acid Canned Foods regulation (21 CFR Part 113). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the observations made at your firm. To date, FDA has not received a response from you regarding the inspectional observations documented during the inspection of your facility.
As a manufacturer of LACF products intended for export to the United States, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the regulations promulgated under the Act. 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 and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 113. Regulations specific to the processing of LACF products are described in 21 CFR 108, and 21 CFR 113.
As outlined in the regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25, 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 108.25(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 108.25, and 21 CFR 113 renders your LACF food 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 Acidified Food regulations through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. You did not process a food in conformity with at least the scheduled process filed with FDA as required by 21 CFR 108.35(c)(3)(i). Specifically,
o All USA shipments of your (b)(4) brand 22g Surimi Soybean Snack (Spicy Flavor) products produced in 2023 were processed at a different time and temperature than the scheduled process you have filed with the FDA. For example, your firm was found to process your (b)(4) brand 22g Surimi Soybean Snack (Spicy Flavor) products at (b)(4)°C for (b)(4) minutes in 2023 even though your filed scheduled identifies a processing temperature of (b)(4)°C ((b)(4)°F) for (b)(4) minutes. Your firm reported that your process authority was not contacted about this change in processing temperature and time.
o Your heat distribution study, which your firm relies on to support your filed scheduled process for surimi soybean snacks, identifies a sterilization temperature of (b)(4)°C for (b)(4)minutes for 20g pouches of soft tofu (soybean snacks). However, your filed scheduled process for (b)(4) brand Surimi Soybean Snack (Spicy Flavor) lists a processing temperature of (b)(4)°C (b)(4)°F) for (b)(4) minutes on 22g pouches. Therefore, your heat distribution study does not adequately support your scheduled process filed with the FDA.
o According to your heat distribution study, which your firm relies on to support your filed scheduled process, your horizontal still water (b)(4) retort was tested while being fully loaded. According to your heat distribution study, fully loaded is defined as 4 baskets with each basket consisting of 4 trays with each tray holding (b)(4)/ 20g pouches of soft tofu pouches (soybean snacks). Therefore, your heat distribution study for your horizontal still water (b)(4) retort was conducted while loaded with (b)(4) 20g pouches. However, during this inspection, our investigator found your firm to estimate that you load approximately (b)(4) 22g pouches for a single retort cycle in a single retort.
o All of your (b)(4) brand USA 22g Surimi Soybean Snack (Spicy Flavor) products produced in 2023 were processed without your firm taking or documenting the initial product temperature. According to your filed scheduled process with the FDA, your firm lists the minimum initial temperature for your surimi soybean snack products as required to be (b)(4)°C ((b)(4)°F). However, your firm does not take the initial temperature of any of your surimi soybean snack products produced for the USA market.
2. Each of your firm’s retorts did not have an accurate temperature-recording device as required by 21 CFR 113.40(b)(2). Specifically, neither of your horizontal still water (b)(4) retorts ((b)(4)) in your surimi soybean processing workshop are equipped with a temperature-recording device. Therefore, your retorts used to process your (b)(4) brand USA 22g Surimi Soybean Snack (Spicy Flavor) products and all other USA surimi snack varieties are not equipped with a sensor or mechanism for recording temperature to a permanent record.
3. Your firm’s processing and production information forms did not include the product, the approximate number of containers per coding interval, the initial temperature, the temperature-indicating device readings, temperature-recording device readings, or appropriate processing data as required by 21 CFR 113.100(a). Specifically, your 2023 processing and production records for your (b)(4) brand USA 22g Surimi Soybean Snack (Spicy Flavor) products failed to document the specific product variety, approximate number of containers per coding interval, initial product temperature, temperature-indicating device readings, and temperature recording device readings. Additionally, as these USA products are produced in a horizontal still water (b)(4) retort, your firm failed to document time steam on, time temperature up to processing temperature, time steam off, and venting time and temperature to which vented. The abovementioned data is also not documented or recorded on processing and production records for any of the LACF products your firm produces for the USA market.
4. Each of your firm’s retort basket that contained retorted food product was not plainly and conspicuously marked with a heat-sensitive indicator or by other effective means to visually indicate the retorted units as required by 21 CFR 113.87(b). Specifically, your firm does not use or document any form of heat-sensitive indicators or other effective means to ensure your baskets have been processed in your horizontal still water (b)(4) retorts used to process your USA low-acid canned food products.
5. The identification code for your firm’s hermetically sealed containers did not identify in code the establishment where packed, product in the container, year packed, day packed, or period during which packed as required by 21 CFR 113.60(c). Specifically, your firm’s only printed identification code for your USA hermetically sealed pouches consists of a 10-month best by date, which does not adequately identify the establishment where packed, the product in the container, year packed, day packed, or period during which packed. For example, the only code printed on your hermitically sealed laminated foil pouch of your USA (b)(4) brand 22g Surimi Soybean Snack (Spicy Flavor) products were found to solely consist of the following example code information: “BEST BEFORE: SEP. 03, 2024”.
6. The reference instrument for indicating the processing temperature was not a temperature-indicating device as required by 21 CFR 113.40(b)(1)(v). Specifically, you do not reference your (b)(4) thermometer to document the retort processing temperature. By the admission of your Equipment & Maintenance Manager, your firm relies on the (b)(4) digital temperature control probe display to document the processing temperatures on your horizontal still water (b)(4) retorts ((b)(4)) used to process LACF products for the USA market.
7. Operators of processing systems and retorts are not under the operating supervision of a person that has attended and satisfactorily completed, a school approved by the Commissioner as required by 21 CFR 113.10. Specifically, your General Manager, Assistant Quality Control Manager, and your Equipment & Maintenance Manager, none of your processing system or retort operators have ever attended training for thermally processing low-acid canned foods, such as a Better Process Control School, nor are they under the supervision of anyone who has completed such training.
During the inspection, you stated you plan to relocate your current operations January 2024 to Jianshe Road, Sanfeng Industrial Park, Huarong County, Yueyang City, Hunan, China 414200. Please note, if you move facilities, equipment, etc., we expect you to address the deviations outlined in this letter, but also comply with the registration/process filing requirements in 21 CFR Part 108 as you will have to obtain a new Food Canning Establishment (FCE) number and establish and file new LACF processes for the products that you intend to process at the new location, etc.
You should respond in writing within (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 such as copies of your updated process filings and completed processing records demonstrating your firm’s ability to adhere to your scheduled process and monitoring of critical factors. 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 do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
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 LACF 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 acidified 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 https://www.accessdata.fda.gov/cms_ia/importalert_1132.html.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR Parts 108, LACF 21 CFR 113, and the CGMP & PC rule (21 CFR 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at rosemary.sexton@fda.hhs.gov. Please reference CMS 673799 on any submissions and within 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
The U.S. Food and Drug Administration (FDA) inspected your low acid canned food (LACF) facility, located at Sanfeng Industrial Park, Huarong County, Yueyang, Hunan, 414200, China, on November 20 through 23, 2023. During that 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 Part 108), the Low Acid Canned Foods regulation (21 CFR Part 113). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the observations made at your firm. To date, FDA has not received a response from you regarding the inspectional observations documented during the inspection of your facility.
As a manufacturer of LACF products intended for export to the United States, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the regulations promulgated under the Act. 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 and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 113. Regulations specific to the processing of LACF products are described in 21 CFR 108, and 21 CFR 113.
As outlined in the regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25, 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 108.25(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 108.25, and 21 CFR 113 renders your LACF food 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 Acidified Food regulations through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. You did not process a food in conformity with at least the scheduled process filed with FDA as required by 21 CFR 108.35(c)(3)(i). Specifically,
o All USA shipments of your (b)(4) brand 22g Surimi Soybean Snack (Spicy Flavor) products produced in 2023 were processed at a different time and temperature than the scheduled process you have filed with the FDA. For example, your firm was found to process your (b)(4) brand 22g Surimi Soybean Snack (Spicy Flavor) products at (b)(4)°C for (b)(4) minutes in 2023 even though your filed scheduled identifies a processing temperature of (b)(4)°C ((b)(4)°F) for (b)(4) minutes. Your firm reported that your process authority was not contacted about this change in processing temperature and time.
o Your heat distribution study, which your firm relies on to support your filed scheduled process for surimi soybean snacks, identifies a sterilization temperature of (b)(4)°C for (b)(4)minutes for 20g pouches of soft tofu (soybean snacks). However, your filed scheduled process for (b)(4) brand Surimi Soybean Snack (Spicy Flavor) lists a processing temperature of (b)(4)°C (b)(4)°F) for (b)(4) minutes on 22g pouches. Therefore, your heat distribution study does not adequately support your scheduled process filed with the FDA.
o According to your heat distribution study, which your firm relies on to support your filed scheduled process, your horizontal still water (b)(4) retort was tested while being fully loaded. According to your heat distribution study, fully loaded is defined as 4 baskets with each basket consisting of 4 trays with each tray holding (b)(4)/ 20g pouches of soft tofu pouches (soybean snacks). Therefore, your heat distribution study for your horizontal still water (b)(4) retort was conducted while loaded with (b)(4) 20g pouches. However, during this inspection, our investigator found your firm to estimate that you load approximately (b)(4) 22g pouches for a single retort cycle in a single retort.
o All of your (b)(4) brand USA 22g Surimi Soybean Snack (Spicy Flavor) products produced in 2023 were processed without your firm taking or documenting the initial product temperature. According to your filed scheduled process with the FDA, your firm lists the minimum initial temperature for your surimi soybean snack products as required to be (b)(4)°C ((b)(4)°F). However, your firm does not take the initial temperature of any of your surimi soybean snack products produced for the USA market.
2. Each of your firm’s retorts did not have an accurate temperature-recording device as required by 21 CFR 113.40(b)(2). Specifically, neither of your horizontal still water (b)(4) retorts ((b)(4)) in your surimi soybean processing workshop are equipped with a temperature-recording device. Therefore, your retorts used to process your (b)(4) brand USA 22g Surimi Soybean Snack (Spicy Flavor) products and all other USA surimi snack varieties are not equipped with a sensor or mechanism for recording temperature to a permanent record.
3. Your firm’s processing and production information forms did not include the product, the approximate number of containers per coding interval, the initial temperature, the temperature-indicating device readings, temperature-recording device readings, or appropriate processing data as required by 21 CFR 113.100(a). Specifically, your 2023 processing and production records for your (b)(4) brand USA 22g Surimi Soybean Snack (Spicy Flavor) products failed to document the specific product variety, approximate number of containers per coding interval, initial product temperature, temperature-indicating device readings, and temperature recording device readings. Additionally, as these USA products are produced in a horizontal still water (b)(4) retort, your firm failed to document time steam on, time temperature up to processing temperature, time steam off, and venting time and temperature to which vented. The abovementioned data is also not documented or recorded on processing and production records for any of the LACF products your firm produces for the USA market.
4. Each of your firm’s retort basket that contained retorted food product was not plainly and conspicuously marked with a heat-sensitive indicator or by other effective means to visually indicate the retorted units as required by 21 CFR 113.87(b). Specifically, your firm does not use or document any form of heat-sensitive indicators or other effective means to ensure your baskets have been processed in your horizontal still water (b)(4) retorts used to process your USA low-acid canned food products.
5. The identification code for your firm’s hermetically sealed containers did not identify in code the establishment where packed, product in the container, year packed, day packed, or period during which packed as required by 21 CFR 113.60(c). Specifically, your firm’s only printed identification code for your USA hermetically sealed pouches consists of a 10-month best by date, which does not adequately identify the establishment where packed, the product in the container, year packed, day packed, or period during which packed. For example, the only code printed on your hermitically sealed laminated foil pouch of your USA (b)(4) brand 22g Surimi Soybean Snack (Spicy Flavor) products were found to solely consist of the following example code information: “BEST BEFORE: SEP. 03, 2024”.
6. The reference instrument for indicating the processing temperature was not a temperature-indicating device as required by 21 CFR 113.40(b)(1)(v). Specifically, you do not reference your (b)(4) thermometer to document the retort processing temperature. By the admission of your Equipment & Maintenance Manager, your firm relies on the (b)(4) digital temperature control probe display to document the processing temperatures on your horizontal still water (b)(4) retorts ((b)(4)) used to process LACF products for the USA market.
7. Operators of processing systems and retorts are not under the operating supervision of a person that has attended and satisfactorily completed, a school approved by the Commissioner as required by 21 CFR 113.10. Specifically, your General Manager, Assistant Quality Control Manager, and your Equipment & Maintenance Manager, none of your processing system or retort operators have ever attended training for thermally processing low-acid canned foods, such as a Better Process Control School, nor are they under the supervision of anyone who has completed such training.
During the inspection, you stated you plan to relocate your current operations January 2024 to Jianshe Road, Sanfeng Industrial Park, Huarong County, Yueyang City, Hunan, China 414200. Please note, if you move facilities, equipment, etc., we expect you to address the deviations outlined in this letter, but also comply with the registration/process filing requirements in 21 CFR Part 108 as you will have to obtain a new Food Canning Establishment (FCE) number and establish and file new LACF processes for the products that you intend to process at the new location, etc.
You should respond in writing within (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 such as copies of your updated process filings and completed processing records demonstrating your firm’s ability to adhere to your scheduled process and monitoring of critical factors. 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 do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
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 LACF 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 acidified 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 https://www.accessdata.fda.gov/cms_ia/importalert_1132.html.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR Parts 108, LACF 21 CFR 113, and the CGMP & PC rule (21 CFR 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at rosemary.sexton@fda.hhs.gov. Please reference CMS 673799 on any submissions and within 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
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