# FDA 483 - Serum Institute of India Pvt. Ltd. - April 19, 2022

Source: https://www.keypedia.com/records/483/serum-institute-of-india-pvt-ltd/3a35200c-1d8e-412d-91fa-012ff9fbaa90

> FDA 483 for Serum Institute of India Pvt. Ltd. on April 19, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Serum Institute of India Pvt. Ltd.
- Inspection Date: 2022-04-19
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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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