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# Agency Posts Form-483 for India Vaccine Maker
- URL: https://www.fdaweb.com/agency-posts-form-483-for-india-vaccine-maker/
- Published: 2025-10-03T12:00:00.000Z
- Updated: 2026-09-14T15:23:20.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159985

FDA has posted a five-item FDA Form-483 after inspecting Covid-19 vaccine maker Serum Institute of India’s Maharashtra manufacturing facility 7/2024\. The agency cited the firm over Covid-19 syringe-filling line deficiencies. It also said the company had insufficient data for a validation study related to a redacted manufacturing process. To view the 483, click [here](https://www.fda.gov/media/189042/download?attachment&ref=fdaweb.com).