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WARNING LETTER

Fujian Guangyang Egg Industry Company Limited MARCS-CMS 594964 —

Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Jie Yu, Chairman
Fujian Guangyang Egg Industry Company Limited

Hongxing Village, Jinyang Town
Fuqing Shi
Fuzhou Shi
Fujian Sheng, 350303
China

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
College Park, MD 20740
United States


DEC 26, 2019

WARNING LETTER

Reference #594964

Dear Mr. Yu:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your low acid canned food (LACF) facility, Fujian Guangyang Egg Industry Company Limited, Hongxing Village, Jinyang Town, Fuqing, Fuzhou, Fujian, 350303, China on September 19, 20, and 23, 2019. The inspection revealed serious violations of the Emergency Permit Control regulation [Title 21 of the Code of Federal Regulations, Part 108 (21 CFR 108)] and the Low Acid Canned Foods (LACF) regulation (21 CFR 113). That inspection resulted in FDA's issuance of an FDA-483, lnspectional Observations, listing the violations found at your firm at the conclusion of the inspection. We acknowledge your written responses received October 21, November 6, and December 12, 2019, to the observations made during the FDA inspection of your facility. Our review of your responses determined that your firm has not adequately addressed all the violations related to your LACF products.

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 regulations promulgated under the Act, including those relating to the processing of LACF 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 low-acid foods packaged in sealed containers 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 Part 108 and 21 CFR Part 113.

As outlined in the regulations, a commercial processor of low acid canned foods that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 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 such 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 LACF 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 the acidified food regulations through links in FDA's home page at www.fda.gov.

We note the following significant violations:

1. Your firm's processing and production information was not recorded at the time it was observed, as required by 21 CFR 113.100(a). Specifically, the investigators requested production records for (b)(4) batches, but the records provided were created for our review during the (b)(4) hours it took your firm to produce the records and did not reflect processing and production information recorded at the time of observation. Our review of processing records revealed (b)(4) out of (b)(4) production batches of Cooked Salted Duck Eggs (SID (b)(4)) and Marinated Eggs (SID (b)(4)) destined for the United States (U.S.) contained different copies of (b)(4) operator logs, in which the processing data in one document did not match the data in the other. (b)(4) operator logs created for our review were compared to electronic data captured by your (b)(4) recorders. The written record created for FDA review did not match actual processing conditions for processing times, critical factors, parameters, quantity and number of (b)(4) loads processed. Additionally, our investigators discovered another copy of the operator's log in the (b)(4) operating room that contained different data from the (b)(4) operator logs created for our review.

Your October 21, 2019, and December 12, 2019, responses state that offices have been re-planned and records re-filed and stored. The October 21 response states the records must have been from the original records. Your December 12 response states that employees were fined for making false records. We are unable to evaluate the adequacy of your corrective actions because you did not provide supporting documentation.

2. Your firm failed to maintain records to identify the initial distribution of finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use, as required by 21 CFR 113.100(f). Specifically:

a. During record review of (b)(4) out of (b)(4) batches of product destined for the U.S., the lot code written on shipping documentation did not match the lot code on the production records discovered in the (b)(4) room.

i. (b)(4) operator logs discovered by our investigator in the (b)(4) room had batch records consisting of only the production date. This information is insufficient to identify specific food lots. Batch records should contain product, lot code and batch size information.

ii. The original record used the date as the lot code (i.e. 2019.6.19). The fabricated ones changed the batch record to match what was shipped to the U.S. and adjusted the quantity produced to show that enough of that particular batch was made for the shipment. For example, Marinated Eggs with batch code (b)(4) and shipped to the U.S. on July 7, 2019 were reportedly processed on June 19, 2019 and June 20, 2019. However, the (b)(4) operator log that was discovered during the inspection from the (b)(4) room denotes different batch codes of "(b)(4)" and "(b)(4)" for product manufactured on those dates respectively. In addition, the quantity of product manufactured during these (b)(4) days ((b)(4) units) was less than the documented quantity of product shipped to the U.S. ((b)(4) units).

b. On September 19, 2019, we observed multiple pallets of marinated eggs in clear, unmarked pouches and tea eggs in cups located in your (b)(4) workshop finished product storage area with no identifying code on the individually packaged eggs or identifying the pallets containing clear, unmarked pouches. For product intended for distribution in the U.S., there was no code applied to the individual marinated egg pouches that were combined into a multi-pack unit. There was no way to determine when the marinated eggs were (b)(4)/ processed and, therefore, insufficient records to identify specific food lots.

c. On September 19, 2019, we observed an unlabeled pallet of tea eggs in cups and an unlabeled pallet of single packed marinated eggs in clear pouches. An employee was observed creating a label for the tea cup pallet as produced on September 18, 2019. On September 20, 2019, the unlabeled pallet of single packed marinated eggs in clear pouches was observed with a production label of September 18, 2019. However, this conflicts with the production log from September 18, 2019, and (b)(4) different employee statements that cups and clear pouches were not manufactured on September 18, 2019.

d. Lot codes that are applied to finished product consist of the year, customer batch and product. They do not identify the establishment, date of production or period of packing for the following LACF products:

Product       Lot Code        Production Date          
Marinated Egg      (b)(4) 6/19/19, 6/20/19
Marinated Egg (b)(4) 3/23/19, 3/ 24/19

This information is insufficient to identify the initial distribution of specific food lots.

Your October 21, 2019, and December 12, 2019, responses state that you have implemented new traceability control procedures. You also note that the production batch number has been revised and after "(b)(4)", a label card with product information will be mounted on each product vehicle, and label of semi-finished products will include product name, quantity, batch number and production date. Your responses also state that employees were punished for making false records. We are unable to evaluate the adequacy of your corrective actions because you did not provide adequate supporting documentation.

3. Your firm failed to review temperature-recording device records no later than one working day after the actual process, as required by 21 CFR 113.100(b). These records must be reviewed before shipment or release for distribution, by a representative of plant management who is qualified by suitable training or experience to review all processing and production records for completeness and to ensure that the product received the scheduled process. The records, including temperature-recording device records, must be signed or initialed and dated by the reviewer. Your firm failed to review and initial or sign these records. Specifically:

a. You did not print out or review the electronic data captured by the (b)(4) recorders installed on your (b)(4). (b)(4) out of (b)(4) batches of US product reviewed during the inspection for product shipped to the U.S. did not have any temperature charts included.

b. There is no evidence that the (b)(4) temperature recording chart for each batch was reviewed.

Your October 21, 2019, response states records of (b)(4) have been printed out and reviewed within one working day. Your December 12, 2019, response included a production record stating that you had reviewed the temperature-recording device records. Your response is inadequate because your review of the production record did not identify discrepancies between the actual processing conditions and the filed critical factors in the scheduled process.

4. Your firm failed to record a critical factor specified in the scheduled process as required by 21 CFR 113.100(a). Specifically, you do not maintain a record of flow rate, which is defined as a critical factor for your LACF egg products processed in (b)(4). There are no operator logs or electronic data in your (b)(4) recorder to document the flow rate for the following (b)(4) out of (b)(4) batches of LACF product destined for the U.S.:

SID   Product  Lot(s)
(b)(4) Cooked Salted Egg (b)(4)
(b)(4) Marinated Egg (b)(4)

Your October 21, 2019, response states a flowmeter has been purchased and will be installed by November 11, 2019 and you will notify FDA once installed. The response is inadequate because it does not address food products manufactured after the inspection without monitoring flow rate and how this affects their scheduled process. You provided an additional response on November 6, 2019, with information regarding the installation of a flowmeter and a blank sterilization record. However, we are unable to evaluate the adequacy of your response because you did not address food products manufactured since the inspection and did not provide supporting documentation, such as how employees were trained on the installation and use of the new equipment. Your December 12, 2019, response provided a production record, but this response is inadequate because the documented flow rate is not in agreement with your firm's filed process.

Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

FDA placed your firm on Import Alert #99-38, "Detention Without Physical Examination Due to Inadequate Process Control" on November 6, 2019. Your firm and products will remain on Import Alert #99-38 until you correct all violations completely and FDA confirms your compliance with the LACF regulation, 21 CFR 113. This alert can be found on FDA's web site at: www.accessdata.fda.gov/cms_ia/ialist.html.

If you wish to request removal from Import Alert #99-38, you should address the violations described above. Your request should outline the specific steps you are taking to correct the violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections such as records of thermal processes for your products. Submission of the information in English will assist in our review. You may view Import Alert #99-38 at www.accessdata.fda.gov/cms_ia/importalert _1132.html.

In addition, we provide the following comment:

• Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR Part 113 and 21 CFR Part 117, Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Human Foods Subparts to assist your firm in meeting Current Good Manufacturing Practices (CGMP) requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluates the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.

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 five lot of product produced over at least five 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. 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.

Additionally, section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.

Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at rosemary.sexton@fda.hhs.gov. Please reference case# 594964 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

William A. Correll, Jr.

Director
Office of Comp ranee
Center for Food Safety
    and Applied Nutrition