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

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

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Record Details

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.

Company
Steril-Gene Life Sciences Private Ltd
Inspection Date
December 10, 2019
Product Type
Drugs
Office
Center for Veterinary Medicine
Person
  • Jose F. Velez
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ID · 98cb4747-526c-4ea1-841b-98df21777d32

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