FDA 483 - Shenzhen Oriental Pharmaceutical Co Ltd - January 11, 2019

An FDA inspection conducted from January 7-11, 2019, at Shenzhen Oriental Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in Shenzhen, China, revealed significant observations concerning their quality systems and manufacturing practices. This inspection resulted in a Form FDA 483 being issued to Miao Jin Chuan, Managing Director.

Key observations included critical deficiencies in the investigation of out-of-specification (OOS) results. Specifically, eleven out of eighteen reviewed investigations for APIs, raw materials, and intermediates failed to identify a root cause, provided an incorrect root cause, or had unclear/unsupported findings. Furthermore, investigational testing protocols requiring Quality Assurance pre-approval lacked the necessary signatures, indicating a breakdown in their established Standard Operating Procedures.

The inspection also noted issues with the 2017 Annual Product Review for an API, where confidence intervals for process control were found outside established limits without adequate explanation. Additionally, the firm was observed using inappropriate valves and piping connections in the production train for an API, including in clean room environments crucial for product quality.

These observations highlight a need for the company to implement comprehensive corrective and preventive actions to ensure compliance with current Good Manufacturing Practices (cGMP) and maintain product quality and safety for ingredients intended for the U.S. market. The firm is expected to respond to the FDA outlining their plan to address these critical issues.