FDA EIR - ZHENDE MEDICAL CO., LTD. - April 07, 2016

An FDA routine surveillance inspection of Shaoxing Zhengde Surgical Dressing Co., Ltd. in Shaoxing, China, was conducted from April 4 to April 7, 2016. This inspection, guided by Compliance Program 7382.845 for Medical Device Manufacturers, was a Level II Quality System Inspection Technique (QSIT) covering key subsystems: Corrective and Preventive Action (CAPA), Management Controls, Design Controls, and Production and Process Controls.

During the four-day assessment, the investigator reviewed the firm's quality system records, including standard operating procedures, quality procedures, internal audits, complaints, and employee training. The company specializes in the research, development, manufacturing, and sales of medical devices such as bandages, non-woven swabs, and compression stockings for both domestic and U.S. markets.

Crucially, the inspection concluded with no significant objectionable conditions identified. No FDA-483 Inspectional Observations were issued, and no refusals were encountered. As a result, the inspection was classified as "No Action Indicated" (NAI), meaning no immediate regulatory actions were required from the company based on this assessment. The firm was found to be operating in compliance with applicable medical device regulations.