483
Steril-Gene Life Sciences Private LtdFDA 483 - Steril-Gene Life Sciences Private Ltd - November 17, 2022
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During an inspection of Steril-Gene Life Sciences Private Ltd. in Puducherry, India, the FDA observed significant deviations in aseptic filling operations. Operators failed to follow written production and process control procedures and did not document critical interventions, such as righting fallen vials, which could compromise product integrity and sterility.
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ID · fface9ec-3183-489b-8a76-665e2d937808