FDA 483 - Pharmaron (Beijing) TSP Services Limited - May 24, 2019

Pharmaron, a nonclinical laboratory in Beijing, China, was cited with six observations during an FDA inspection. The inspection revealed significant issues including inadequate cleaning and sanitization of animal care equipment, unsuitable facility construction, failure to retain raw data, unauthorized and undocumented SOP deviations, and a deficient quality assurance unit. Additionally, the firm failed to maintain adequate written records for equipment operations due to illegible printouts.