FDA 483 - Vital Laboratories Pvt Ltd Plant II

Vital Laboratories Pvt. Ltd. in Vapi, Gujarat, an API manufacturer, was inspected by the FDA from August 28 to September 1, 2018. The inspection revealed significant deficiencies in documentation practices, including missing data in batch production records, inadequate investigation of complaints and deviations, and poor control over manufacturing environments and labeling. The firm also had issues with inadequate Standard Operating Procedures and environmental control in the sample room.