FDA EIR - Conod Medical Co., Limited - December 13, 2018

A comprehensive Level 2 Quality System Inspection Technique (QSIT) inspection of Conod Medical Co., Limited, a foreign contract manufacturer of sterile single-use medical devices, took place from December 10-13, 2018, in Changshu, China. The inspection, conducted under Compliance Program 7382.845, assessed the firm’s adherence to the Quality System Regulation's current Good Manufacturing Practices (cGMPs), Medical Device Reporting (MDR), and Unique Device Identifier (UDI) Regulations. The inspection covered Management Controls, Design Controls, Corrective and Preventive Action (CAPA) Controls, and Production and Process Controls, with a focus on sterile urine drainage bags.

Notably, no Form FDA 483 (Inspectional Observations) was issued to Conod Medical at the conclusion of this inspection. However, a key issue discussed with management involved the sterilization process documentation. Specifically, the Device History Records (DHRs) for routine sterilization processing utilized a four-day biological indicator incubation period, while the approved validation studies referenced a seven-day period. There was no clear justification or reference in the DHRs for this discrepancy. Management committed to addressing this point by referencing the biological indicator incubation time reduction validation study in the sterilization cycle documentation to ensure complete record-keeping. The firm exports Class 1 and Class 2 medical devices to the U.S. and maintains ISO 13485 certification.