# FDA 483 - Serum Institute of India Pvt. Ltd. - July 02, 2024

Source: https://www.globalkeysolutions.net/records/483/serum-institute-of-india-pvt-ltd/efcd0153-0986-40dd-9ac6-c0b4618419b8

> FDA 483 for Serum Institute of India Pvt. Ltd. on July 02, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Serum Institute of India Pvt. Ltd.
- Inspection Date: 2024-07-02
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Serum Institute of India Pvt. Limited Manjari Site in Pune, India, revealed significant deficiencies in vaccine manufacturing processes. Observations included inadequate requalification of equipment for COVID vaccine filling, insufficient data to support cleaning processes between different vaccine products, and an incomplete validation study. The firm also lacked data in qualification reports for reference standards and failed to fully investigate critical defects.

## Related Documents

- [483 - 2022-04-19](https://www.globalkeysolutions.net/records/483/serum-institute-of-india-pvt-ltd/3a35200c-1d8e-412d-91fa-012ff9fbaa90)
- [483 - 2024-02-02](https://www.globalkeysolutions.net/records/483/serum-institute-of-india-pvt-ltd/64363ae7-2eda-42d2-9d2c-4e4d40f60fae)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/anissa-cheung/28959f30-f1e9-43a0-bec8-efd114e8cec2)
- [Latorie Jones, Investigator](https://www.globalkeysolutions.net/people/latorie-jones-investigator/69bab050-54e2-421e-baa8-ac4c3dc7c97a)
- [Pankaj Amin, CSO](https://www.globalkeysolutions.net/people/pankaj-amin-cso/d01a4c72-08cd-409e-99bc-3e54afcbd17a)

Company: https://www.globalkeysolutions.net/companies/serum-institute-of-india-pvt-ltd/a1288932-02ec-49e6-942a-e8d90c93b890

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd