China NMPA Inspection - Yake Medical Products (Beijing) Co., Ltd. - November 03, 2017

Yake Medical Products (Beijing) Co., Ltd. recently underwent an unannounced inspection by the State Food and Drug Administration regarding its medical absorbable sutures. The inspection revealed critical deficiencies throughout its quality management system, indicating non-compliance with the "Good Manufacturing Practice for Medical Devices" and related appendices. Main issues included equipment problems, such as sealing machine speed discrepancies, missing UV lamp replacement records, and inaccurate force gauges for critical strength testing. Document management procedures for Quality Manual destruction were not followed, and incoming goods inspection was inadequate, relying on supplier reports without internal verification.

Significant deficiencies in production management included a lack of proper identification and traceability for finished products, non-conforming items, and raw materials. Suture storage conditions lacked a documented basis and instrument calibration records. Sterilization records showed inconsistencies in process parameters, missing biological indicator information, and absent positive control data. Furthermore, the sterilization process validation was incomplete, lacking loading diagrams, re-validation methods, and initial contamination reports. Lastly, critical quality control instruments, specifically sealing machine temperature controls, were found uncalibrated. Yake Medical Products is required to implement comprehensive corrective actions to address these systemic deficiencies and ensure full compliance with regulatory standards.