The US FDA conducted an onsite inspection of our R&D Center located in Shanghai between Aug 12 and Aug 16, 2019.
This inspection was mainly aimed at the products registered in the US FDA. The Agency conducted the inspection in the form of opening meeting, R&D facility tour, interviews, documents review, and close out meeting. During the inspection, the inspector mainly focused on quality system, analytical laboratory management and instrument management. Company senior management, related department head and project team members participated in the above activities as required. The quality system and the operation of R&D center had been recognized by FDA inspector. R&D center passed the inspection without 483.
Warmly congratulations to SINOT team for another successfully passing FDA inspection!
Shanghai Head Office
99 Haike Road, Bldg. 3, 1st Flr., Pudong District Shanghai 201210, P.R. China
Manufacturing Site in Jiangsu
No. 163 Zhuhai Road, Haimen Area, Nantong City, Jiangsu Province
