FDA 483 - Bushu Pharmaceuticals Ltd. - December 02, 2022

This FDA Form 483 document details observations from an inspection, highlighting deficiencies in quality control and facility management.

**Observation 1** addresses the quality control unit's responsibilities and procedures not being fully written or followed. Specifically: * Complaint records for on-site investigations (Procedure 141.0-QA) are incomplete, lacking full documentation or justification for reported actions. Evaluation of retention samples is not fully described (e.g., quantity, inspection steps, timeliness). Complaints citing "Lack of Efficacy" (e.g., "b) <4) -l Tabs~~ mg CHK2003-004 /2003-005") only included visual inspection, not analytical testing. * Deviation reports (Procedure 1B7.0QA) are not always fully documented to support conclusions or "no further actions." For instance, Deviation report DVK210238 (16Dec2021) for failed disintegration tests in "b) <4) mg Lot fbl < )7 and fbl < )7" (results NMTl min) resulted in no additional actions after an evaluation, and both lots were released.

**Observation 3** identifies deficiencies in separate or defined areas and control systems to prevent contamination or mix-ups. Specifically: * Records of abnormal events in Manufacturing Building [redacted] (SOP 411