483
Steril-Gene Life Sciences Private LtdFDA 483 - Steril-Gene Life Sciences Private Ltd - November 17, 2022
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During an inspection from November 17-25, 2022, the FDA observed Steril-Gene Life Sciences Private Ltd. in Puducherry, India, failing to follow and document written production and process control procedures. Specifically, operators performing aseptic filling interventions with lay-down vials did not document these actions, potentially compromising product integrity and sterility. This indicates a significant lapse in adherence to established manufacturing controls.
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