China NMPA Inspection - Anhui Aerospace Biotechnology Co., Ltd. - October 11, 2018

Anhui Aerospace Biotechnology Co., Ltd. underwent an unannounced compliance inspection from September 5th to September 7th, 2018, based on the Good Manufacturing Practice for Medical Devices. The inspection revealed significant deficiencies in the company's quality management system for products such as medical holmium (Ho:YAG) laser therapy machines.

Two serious violations were identified. The company failed to maintain proper product traceability, specifically lacking records to link key components like holmium rods to the serial numbers of finished products (Article 50). Additionally, finished product inspection reports (Article 58) for the medical holmium laser therapy machine indicated compliant results for critical parameters but lacked corresponding original test data, raising concerns about product quality verification.

Four general deficiencies were also noted: improper storage of product casings (Article 17), unrecorded borrowing of testing equipment (Article 22), the use of an outdated document version for equipment usage records in a production workshop (Article 25), and the inability to provide a calibration certificate for a liquid turbine flow meter (Article 57).

In response to these findings, particularly the serious issues, the Anhui Provincial Food and Drug Administration, referencing the "Regulations on the Supervision and Administration of Medical Devices" (State Council Decree No. 680), ordered Anhui Aerospace Biotechnology Co., Ltd. to immediately suspend production for comprehensive rectification. The company must assess product safety risks, recall any potentially hazardous products, and publicly disclose its rectification progress. Production can only resume after all deficiencies are fully addressed and a subsequent re-inspection by the Provincial Administration is successfully passed.