# FDA 483 - Granules India Limited - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/granules-india-limited/64b772a2-346d-4bf1-b631-09003e41fb59

> FDA 483 for Granules India Limited on January 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Granules India Limited
- Inspection Date: 2023-01-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Granules India Limited, a drug product manufacturer in Telangana, India, was cited for significant deficiencies in quality control and manufacturing processes. Observations included failures to thoroughly investigate out-of-specification results, unrecorded deviations from procedures, and a lack of adequate written procedures and process understanding for drug product manufacturing and validation. These issues indicate a systemic weakness in ensuring drug product identity, strength, quality, and purity.

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## Related Officers

- [Jogy George](https://www.globalkeysolutions.net/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)

Company: https://www.globalkeysolutions.net/companies/granules-india-limited/e2f27ea6-6e3b-4432-a874-d34393d76014

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1