Shanghai Institute of Measurement and Testing Technology Co., Ltd. – FDA 483, Jul 23, 2026

An FDA inspection of Shanghai Institute of Measurement and Testing Technology Co, Ltd in Shanghai, China, revealed significant deficiencies in laboratory controls. Observations included the use of unqualified analytical equipment for particle size distribution testing and inadequate controls for computerized systems, such as lack of password authentication and disabled audit trails. These issues indicate a lack of proper data integrity and quality system management.