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

Source: https://www.keypedia.com/records/483/serum-institute-of-india-pvt-ltd/64363ae7-2eda-42d2-9d2c-4e4d40f60fae

> FDA 483 for Serum Institute of India Pvt. Ltd. on February 02, 2024. 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: 2024-02-02
- 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, a vaccine manufacturer in Pune, India, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate requalification of equipment for COVID vaccine filling, insufficient data to support cleaning processes and validation studies, and a failure to thoroughly investigate critical defects and implement effective corrective actions. These issues indicate a lack of robust quality systems necessary for vaccine production.

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## Related Officers

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

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

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