Jiangsu Shenli Medical Production Co., Ltd.

During an inspection of your firm Jiangsu Shenli Medical Production Co., Ltd., located at No. 20 Changzheng Road, Zhengluzhen, Wujin, Changzhou, Jiangsu, China on March 25 through March 29, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a contract and private label manufacturer of sterile and non-sterile syringes, intended to inject fluids into or withdraw fluids from the body. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received responses from Liqun Yang dated April 17, 2024, April 30, 2024, and May 30, 2024, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1).

Specifically, your firm has no documentation related to design and development activities for your bulk Non-Sterile Luer Lock syringe sizes 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 60 mL; Sterile Luer Lock syringe sizes 3 mL, 6 mL, 12 mL, 20 mL, 35 mL, 60 mL, 100 mL; and bulk Non-Sterile Luer Slip syringe sizes 1 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 60 mL, exported and intended for the US market that includes: a. Design Input b. Design Output c. Design Review d. Design Verification e. Design Validation to include Risk Analysis f. Design Transfer g. Design Changes h. Design History File

Additionally, your firm has no design and development documentation for your Enteral Feeding Syringes with ENfit connector Model: 10 ml and 60 ml control ring.

The adequacy of your firm’s responses cannot be determined at this time. Your responses indicate that you have opened CAPA 2024-0407 to address this citation and that the design and development procedure will be revised to ensure alignment with the necessary requirements related to design planning, input, output, review, verification, validation, transfer, and changes, and that you will verify that other products being exported to the United States contain a DHF. However, documentation or evidence of completed corrective actions was not provided, including the results of your retrospective analysis of other products as well as corrective actions conducted as a result of your investigation into the root-cause(s) associated with the failure to implement your design control procedures, and verification and/or validation that the corrective actions (including implementation of design controls for all products that currently lack them) were effective, prior to their implementation, to prevent recurrence of these violations.

2. Failure to establish and maintain device master records, as required by 21 CFR 820.181.

Specifically, you have not established a Device Master Record (DMR) for your line of private label manufactured syringes under K103830 and syringes with various colors, sizes and connection types without market clearance or approval exported and intended for the US market. Your firm has no documentation to include:

a. Device specifications including appropriate drawings, composition, formulation, and component specifications; b. Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; c. Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; d. Packaging and labeling specifications, including methods and processes used; and e. Installation, maintenance, and servicing procedures and methods.

The adequacy of your firm’s responses cannot be determined at this time. Your responses indicate that you have opened CAPA 2024-0406 to address this observation, and mentioned that you will establish a DMR procedure, train relevant personnel, submit a new 510k submission for syringes outside the scope of K103830 cleared products, and organize DMRs for other 510ks not related to K103830. However, documentation or evidence of completed corrective actions was not provided, including but not limited to, evidence of completion of the activities proposed in your remediation plan and documentation demonstrating that your corrective actions have been evaluated for effectiveness.

Given the serious nature of the violations of the Act, sterile and non-sterile syringes manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA has taken steps to refuse entry of devices under product code FMF into the United States, known as “detention without physical examination.” FDA will take steps to refuse entry of additional devices under product code PNR into the United States, known as “detention without physical examination,” until these violations are addressed. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and address the violation(s) described in this letter. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or 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 business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent by email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 687035 when replying. If you have any questions about the contents of this letter, please contact: Shruti Mistry at shruti.mistry@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.