FDA 483 - Sionc Pharmaceuticals Private Limited, Unit II - February 07, 2020

Sione Pharmaceuticals Private Limited in Parawada, India, was cited for significant deficiencies in its manufacturing processes. The inspection revealed a lack of written procedures for production and process controls, specifically concerning process validation for API, which included insufficient batch assessment and missing microbial content evaluation. Additionally, the firm failed to follow and adequately detail written procedures for equipment cleaning and maintenance, with multiple issues identified in cleaning validation studies.