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WARNING LETTER

Delori Industrial Co., Ltd. MARCS-CMS 605380 —


Delivery Method:
Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Jihuan Wu
Recipient Title
President
Delori Industrial Co., Ltd.

NO. 799 Hengshan West Road
Beilun Qu
Ningbo Shi
Zhejiang Sheng, 315800
China

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

United States


WARNING LETTER

Reference #: 605380

Dear Mr. Jihuan Wu,

The U.S. Food and Drug Administration (FDA) inspected your acidified food (AF) firm, Delori Industrial Co., Ltd. located at, No. 799 Hengshan West Road, Beilun District, Ningbo, Zhejiang, 315800 China on October 28 to 30, 2019. 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) and the Acidified Foods regulation (21 CFR Part 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, lnspectional Observations that lists the serious deviations found at your firm. We acknowledge your firm's response received on November 20, 2019, which included descriptions of partial corrections taken by your firm and planned timeframes for remaining corrections. On January 22, 2020, we responded with a request for an update on your remaining corrections to which you replied your facility was closed until February 2020 and requested additional time to respond. On February 19, 2020, we received your response which included descriptions of your remaining corrections to the observations of concern noted on the form FDA-483. On March 6, 2020, you replied to our followup questions. Our review of your response determined that your firm has not addressed all the violations related to your acidified food products, as further described in this letter.

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 Federal regulations relating to the processing of acidified foods. 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 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 Parts 114. Regulations specific to the processing of acidified food products are described in 21 CFR 108 and 21 CFR 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 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 114 renders your acidified dairy beverage 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.

Your significant violations are as follows:

1. Your firm failed to process each acidified food in conformity with at least the scheduled process, as required by 21 CFR 108.25 (c)(3). Your firm's filed scheduled processes for your dairy beverages in (b)(4)ml bottles identifies a finished equilibrium pH of (b)(4) and a minimal thermal processing method of (b)(4)°C for (b)(4) minutes. However, you did not ensure your product was processed within the limits specified in the scheduled process. Specifically,

  • You do not monitor the actual time your product is processed at the scheduled process temperature of (b)(4)°C. You monitor the time the (b)(4) bottle enters and exits the (b)(4) pasteurizer. Your pasteurizer contains (b)(4) zones, each set to different temperatures. You estimate that that when the product is in the (b)(4) pasteurizer for (b)(4) total minutes it is in the (b)(4) zones above (b)(4)°C for approximately (b)(4) minutes, the minimum process time for your acidified dairy beverage products. However, due to lack of supporting records you were unable to demonstrate or verify the minimum process time of (b)(4) minutes at (b)(4)°C was met when product dwell time in the (b)(4) pasteurizer was (b)(4) minutes.
  • During our inspection, our investigator observed that you did not consistently monitor the time of product entering or exiting the pasteurizer, as the processing times were either missing or incomplete for (b)(4) of (b)(4) batch records for product primarily intended for shipment to the US. In your response to the FDA-483, you provided measurements for the zones in your pasteurizer, to support your estimated process time; however, these measurements conflict with those taken during the inspection by your production manager and our investigator. Based on the measurements taken during the inspection, a dwell time of (b)(4) minutes would provide a process time at (b)(4)°C less than your minimum scheduled process. You must have actual time and temperature recordings for your thermal process.

2. Your firm's operators are not under the supervision of a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, and critical factors in acidification, and who has satisfactorily completed the prescribed course of instruction, as required by 21 CFR 108.25(f). Specifically, you told (b)(4). This lack of training was evidenced by your inability to identify to our investigator your scheduled processes for the products you ship to the US. Further, our review of your thermal process monitoring records, which had been reviewed by your quality control and production managers, showed that your employees recorded process times that did not correlate with actual times written, were missing entirely, or did not meet your minimum requirement of (b)(4) minutes. These records indicate your employees lack adequate training and supervision on monitoring of critical factors for your acidified processes.

In your emailed response to the FDA 483 you stated that someone at your firm will attend the FDA Better Process Control School in China. If you have completed a course or otherwise implemented this correction, please submit documentation demonstrating successful completion with your response to this letter.

Additional Comments:
During our inspection you mentioned that you are in the process of building a new manufacturing plant in which you plan to manufacture products shipped to the US. As a manufacturer of acidified food products, you are required to register your new facility as a food canning establishment and file the scheduled processes associated with the new facility, prior to shipping products to the US.

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 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 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, 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 114) 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 Acidified Foods regulation (21 CFR 114) and the current Good Manufacturing Practice regulation (21 CFR 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

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: Aleta Flores, 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 aleta.flores@fda.hhs.gov. Please reference #CMS 605380 on any submissions and within the subject line of any emails to us.

Sincerely,

/S/

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

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