FDA 483 - Shenzhen Oriental Pharmaceutical Co Ltd - January 07, 2019

Shenzhen Oriental Pharmaceutical Co., Ltd., an API manufacturer in Longgang District, Shenzhen, China, was cited with four observations during an FDA inspection. The inspection revealed significant issues with out-of-specification investigations, lack of Quality Assurance preapproval for testing protocols, unexplained deviations in annual product reviews, and concerns regarding valve and piping connections in cleanroom production areas. These findings indicate deficiencies in quality control and manufacturing processes.