483
Apitoria Pharma Private LimitedApitoria Pharma Private Limited – FDA 483, Dec 1, 2025
Record Details
An FDA inspection of Apitoria Pharma Private Limited, a sterile API manufacturer in J.N.Pharamacity, Telangana, India, revealed significant deficiencies in aseptic processing. Observations included inadequate airflow visualization studies for aseptic filling lines, a lack of environmental sampling to support cross-contamination controls, and an aseptic process simulation study that failed to assess worst-case challenge organisms.
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ID · 6f5e5d42-b274-40c8-a6ea-1599f903fa48
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