Jiangsu Caina Medical Co., Ltd – FDA Warning Letter, Mar 23, 2024

The FDA issued a Warning Letter to a firm in Jiangyin City, Jiangsu, China, following an inspection from March 11-23, 2024. The firm manufactures medical devices, including Sterile Luer Lock Syringes without Needles and Sterile Enteral Syringes, which are deemed 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 adequately establish and maintain CAPA procedures (21 CFR 820.100(a))**: The firm did not analyze quality data to identify causes of nonconforming products. Specifically, at least 41 US market complaints regarding syringe pump incompatibility and/or incorrect volume detection for "Monoject" branded syringes (K113091, K190502) were not adequately investigated or led to timely CAPA initiation. For example, complaints 20230705 and 20231008, detailing pump incompatibility and inaccurate dosing, were closed without opening CAPAs, despite confirming issues. This contributed to delayed recognition of risks, leading to Class I recalls by Cardinal Health in September and December 2023. The firm's responses were inadequate, lacking evidence of effective implementation of new procedures or complete