FDA 483 - Strides Pharma Science Limited - February 05, 2019

An FDA inspection of Strides Pharma Science Limited in Puducherry, India, revealed significant deficiencies across multiple systems, indicating a lack of adequate controls. Key issues included inadequate Out-of-Specification investigations, insufficient employee training, and poor equipment cleaning and maintenance. Additionally, critical GMP records were improperly discarded, batch records were not contemporaneously maintained, and computer systems lacked proper controls and audit trails, highlighting severe quality control and data integrity concerns.