FDA EIR - Promisemed Hangzhou Meditech Co., Ltd - March 13, 2015

An FDA inspection of Promisemed Hangzhou Meditech Co., Ltd., a contract manufacturer of sterile Class II medical devices, including insulin syringes and pen needles for the U.S. market, was conducted from March 9 to March 13, 2015. This was the firm's initial Level II Baseline Quality System Inspection Technique (QSIT) evaluation. The inspection covered critical aspects of the company's operations under the regulatory framework, specifically assessing Management Controls, Corrective and Preventive Actions (CAPA), and Production and Process Controls. Notably, the inspection concluded without the issuance of an FDA Form 483, which indicates no significant objectionable conditions or violations were observed. The report highlights the firm's collaboration with Simple Diagnostics, the specification developer, in establishing Device Master Records and other critical manufacturing processes. No main violations or issues were identified, and management was cooperative throughout the five-day inspection. Consequently, no specific regulatory actions were required from Promisemed Hangzhou Meditech Co., Ltd. at the time of this report.