FDA WARNING_LETTER - Jiangsu Shenli Medical Production Co., Ltd. - March 29, 2024

On March 25-29, 2024, an FDA inspection of Jiangsu Shenli Medical Production Co., Ltd. in China, a manufacturer of sterile and non-sterile syringes, revealed that their devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a)(1))**: The firm lacked design and development documentation (e.g., design input, output, review, verification, validation, transfer, changes, Design History File) for various bulk non-sterile and sterile Luer Lock/Slip syringes and Enteral Feeding Syringes intended for the US market. The firm's responses, including CAPA 2024-0407, were deemed inadequate as no evidence of completed corrective actions, retrospective analysis, root-cause investigation, or effectiveness verification was provided. 2. **Failure to establish and maintain device master records (21 CFR 820.181)**: The firm lacked Device Master Records (DMRs) for private label syringes under K103830 and other syringes exported to the US without market clearance. Missing documentation included device specifications, production process specifications, quality assurance