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WARNING LETTER

Lianyungang Aikang Food Co., Ltd MARCS-CMS 593495 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Chuanai Li
Recipient Title
President
Lianyungang Aikang Food Co., Ltd

118 Qianjin South Road, Chaoyang Town, Development Zone
Lianyungang Shi
Jiangsu Sheng, 222068
China

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

5001 Campus Drive
College Park, MD 20740-3835
United States


DEC 4, 2019

WARNING LETTER

Reference #593495

Dear Mr. Li:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your acidified food facility, Lianyungang Aikang Food Co., Ltd., located at 118 Qianjin South Road, Chaoyang Town, Development Zone, Lianyungang City, Jiangsu, 222068, China on July 8 and 9, 2019. The inspection revealed serious violations of the Emergency Permit Control regulation [Title 21 of the Code of Federal Regulations (CFR), Part 108 (21 CFR Part 108)] and the Acidified Foods (AF) regulation (21 CFR Part 114). 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 response dated July 30, 2019, to the observations made during the FDA inspection of your facility. Our review of your response determined that your firm has not adequately addressed all the violations related to your acidified food products.

As a manufacturer of acidified food 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 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 low-acid foods packaged in 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 114. Regulations specific to the processing of acidified food products are described in 21 CFR Part 108 and 21 CFR Part 114.

As outlined in the regulations, a commercial processor of acidified foods that does not adhere to all of the mandatory requirements of 21 CFR 108.25 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 108.250) 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 108.25 and 21 CFR Part 114 renders your acidified 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 the acidified food regulations through links in FDA's home page at www.fda.gov.

We note the following significant violations:

1. Your firm failed to implement appropriate quality control procedures, including frequent testing and recording of results, to ensure that finished foods do not present a health hazard as required by 21 CFR 114.80(a). Specifically:

a. On July 9, 2019 at 14:29, our investigator observed a pH test result record in the laboratory desk area for canned peaches dated July 9, 2019 that contained entries that could not have been the result of actual testing because the entries reflected contemporaneous and future times ("(b)(4)", "(b)(4)", and "(b)(4)"). Your laboratory employee then presented a second record for the same product dated June 9, 2019 completed with times prior to 14:29. During the close out of the inspection, our FDA investigator explained that records have to be documented at the time that the activity is observed or conducted to reflect actual testing results. These pre-filled records demonstrate a lack of appropriate quality control procedures.

b. On July 9, 2019 at 14:29, our investigator observed sweet packing fluid mixing records in the laboratory desk area filled with data and dates ((b)(4)) but with no associated product information entered on the records. When the individual dates of the mixing records were compared to manufacturing records in the record room, it was observed that there were either no manufacturing records for such dates or there was a duplicate of the record for that date containing conflicting data. Specifically, the FDA investigator noted a record of the packing fluid mixing record dated "(b)(4)" stapled in the complete batch record located in the firm's record room and compared it with packing fluid mixing records dated "(b)(4)" found in the laboratory and determined that the (b)(4) records for the packing fluid mixing for the same date contained different testing results. These mixing records with no matching or conflicting manufacturing records demonstrate a lack of appropriate quality control procedures.

In a post-inspectional " Letter of apology to FDA inspection panel" dated July 11, 2019, your firm has implemented "(b)(4)" within your processing facility. Your July 30, 2019, response indicated products were re-tested, that you updated management and training Standard Operating Procedures (SOPs) and responsibilities, that you updated Corporate Integrity Management System and Employee Reward and Punishment System procedures, and provided training records, specifically for the canned peach products. We are unable to evaluate the adequacy of your response because you did not provide supporting documentation specific to the issue of pre-filled records and records with no matching manufacturing records.

2. You did not test and examine containers often enough to ensure that the containers suitably protected the food from leakage and contamination as required by 21 CFR 114.80(a)(4). Specifically, your firm is not conducting frequent can examinations to identify dented cans during the different processing steps. On July 8, 2019 and July 9, 2019, we observed multiple cans with significant deformation in close proximity to the can seams. Damaged cans were observed throughout the facility at the following production (b)(4): prior to syrup addition, after exiting the lid sealer machine, after the (b)(4) step, and in finished product storage.

Your July 30, 2019, response indicated you contracted with Shandong Keno Machinery Technology to conduct a field analysis on can deformation and inspection for incoming cans. However, we are unable to evaluate the adequacy of your response because you did not provide supporting documentation. Your response did not include the type of testing being conducted on finished product cans for FDA review. Also, the response did not address the disposition of the deformed cans observed during the inspection and inspected by Shandong Keno Machinery Technology.

3. You did not maintain processing and production records showing adherence to the scheduled process as required by 21 CFR 114.100(b). Specifically:

a. No production records were available for the manufacture of (b)(4) cans, size (b)(4) grams, of peach products manufactured on July 5, 2019, and identified as: (b)(4) and (b)(4) cans of the same product manufactured on July 6, 2019, with the following manufacturing information: (b)(4).
b. On July 8, 2019 we conducted a review of your firm's processing records and identified the following failures to maintain processing and production records:

i. No pH meter calibrations records were available. Processing and production records must include records of pH measurements and other critical factors intended to ensure a safe product.

ii. Production records were missing product information including lot number, product name, production date, and/or container size. Processing and production records must include sufficient information such as product code, date, container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production.

iii. We observed an employee entering the time of (b)(4) when the actual time was (b)(4) into a production record at the lid sealing machine area. Records must be documented at the time that the activity is observed or conducted to ensure that the record accurately reflects adherence to the scheduled process.

Your July 30, 2019, response indicated you implemented the Staff Penalty Decision procedure and punishments and established document control procedures as well as record review and retention procedures. The response also indicated you conducted re-training. However, we are unable to evaluate the adequacy of your response because you did not include supporting corrective action documentation of manufacturing records for FDA review to ensure your firm is adhering to the filed scheduled process for canned peaches.

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 October 29, 2019. We acknowledge receipt of information from your firm dated November 23, 2019, received by FDA on December 2, 2019; however, your firm and products will remain on Import Alert #99-38 until you correct all violations identified in this letter as well as issues identified in the Import Alert and FDA confirms your compliance with the Acidified Food regulation, 21 CFR Part 114. This alert can be found on FDA's web site at: www.accessdata.fda.gov/cms_ia/ialist.html.

In addition, we provide the following comments:

• 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 114 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.

• During the inspection, we observed a (b)(4) jar labeled with a preparation date of July 7, 2019, and an expiration date of August 6, 2019. Your firm prepares pH buffer solution from a powder but does not have written instructions for pH buffer solution preparation, storage, or pH meter calibration. We note that pH buffer solution prepared from a powder buffer mix appears to expire a few days after preparation according to the pH buffer manufacturer's website.

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 lots 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# 593495 on any submissions and within the subject line of any emails to us.

Sincerely,

/S/

William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition