# FDA 483 - Granules India Limited - June 20, 2025

Source: https://www.keypedia.com/records/483/granules-india-limited/20298bd3-98c2-4aa3-8184-529439bfb3c0

> FDA 483 for Granules India Limited on June 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Granules India Limited
- Inspection Date: 2025-06-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Granules India Limited, an API manufacturer in Sangareddy District, Telangana, India, was cited for significant failures in documenting and investigating deviations from established procedures. Observations included the approval of a Quality Comparison Report with an incorrect drug name that went uninvestigated for an extended period, and uninvestigated out-of-specification differential pressure readings in a cleanroom corridor. These issues highlight deficiencies in the firm's quality system and deviation management.

## Related Officers

- [Investigator](https://www.keypedia.com/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.keypedia.com/companies/granules-india-limited/eee4b9ba-83d6-4bb9-8d78-bca1e808ad45

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8