483
Serum Institute of India Pvt. Ltd.Serum Institute of India Pvt. Ltd. – FDA 483, Apr 19, 2022
Record Details
The FDA inspection of Serum Institute of India Pvt. Ltd. in Manjari Bk., Pune, revealed significant deficiencies in their manufacturing operations. Key issues included widespread good documentation practices and data integrity failures, inadequate process validation, and a lack of robust systems for deviation reporting, investigations, and timely corrective actions. These findings indicate serious concerns regarding the firm's quality control and compliance with regulatory standards.
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ID · 3a35200c-1d8e-412d-91fa-012ff9fbaa90
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