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

Source: https://www.keypedia.com/records/483/serum-institute-of-india-pvt-ltd/99b21dd6-64bc-486a-9d58-fa9088b5a956

> FDA 483 for Serum Institute of India Pvt. Ltd. on July 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: 2024-07-02
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- 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 prevent cross-contamination between vaccine products, and uncompleted validation studies for critical processes. The firm also lacked qualification data for reference standards and failed to fully investigate critical defects, indicating systemic quality control problems.

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Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4