FDA 483 - Steril-Gene Life Sciences Private Ltd - December 10, 2019

Steril-Gene Life Sciences Pvt Ltd, a sterile drug product manufacturer in Puducherry, India, received a Form 483 with two observations. The inspection revealed deficiencies in following written production control procedures, specifically regarding visual inspection of vials for defects. Additionally, the firm's cleaning validation procedures for manufacturing and sterile holding tanks were found to be inadequate, lacking proper sampling plans and visual inspection instructions.