483
Steril-Gene Life Sciences Private LtdSteril-Gene Life Sciences Private Ltd – FDA 483, Dec 10, 2019
Record Details
Steril-Gene Life Sciences Pvt Ltd, a contract sterile drug product manufacturer in Puducherry, India, was cited with two observations during an FDA inspection. The observations concern failures to follow written production procedures, specifically regarding visual inspection of vials, and deficiencies in cleaning and maintenance procedures for equipment, including inadequate cleaning validation sampling plans for manufacturing tanks.
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ID · 8a3f06bd-b9dc-48ec-840b-bbda2031a3db
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