NMPA Overseas Audit at Medtronic, Inc. in the USA (2019/03/05)

License Holder: Medtronic, Inc.

Address of License Holder:
710 Medtronic Parkway N.E. Minneapolis MN 55432 USA

Manufacturing Site:
3800 Annapolis Lane Plymouth, MN 55447, USA.

China Agent: Medtronic Shanghai

Product: Artificial heart valve

Type of Inspection: Regular Supervision

Guidelines for Inspection: Medical Device GMP, Appendix for Implants

Note: This inspection report is online applicable for the results of the on-site audit. The deficiencies donot cover all the issue that may exist in the company. The manufacturing activities shall comply with the current Chinese medical device laws and regulations and ensure the quality of the device imported to China.

Inspection Results:

A total of 1 defect is found during the on-site inspection:

The water in the clean room is mainly use for the cleaning when a stain is found before the product is packaged, which directly contacts the product. The procedure for environment control
general requirement (Doc. No. 10083272DOC) did not specify the monitoring of the water point conductivity of clean room. The SOP for water system (Doc. No. OP-00-3173) did not specify the periodic validation requirement in the normal manufacturing conditions.

For the above defects, the license holder is responsible for the investigation and validation and makes the rectification as soon as possible. Please inform the NMPA of the rectification in both Chinese and English in the written form within 50 working days after receiving this report. The rectification report shall include the Corrective and Preventive Action for each defect with attached documents. If the rectification can not be done within the required time, the reason asking for prolongation must be given with the planning completing time.