# FDA 483 - GRANULES LIFE SCIENCES PRIVATE LIMITED - December 19, 2025

Source: https://www.globalkeysolutions.net/records/483/granules-life-sciences-private-limited/2cc1875f-a1d3-414c-a754-67c875907e81

> FDA 483 for GRANULES LIFE SCIENCES PRIVATE LIMITED on December 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GRANULES LIFE SCIENCES PRIVATE LIMITED
- Inspection Date: 2025-12-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Granules Life Sciences Pvt Ltd, a drug product manufacturer in Medchal-Malkajgiri, India, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included inadequate cleaning validation and equipment maintenance, poor environmental control with widespread powder contamination, and a systemic failure to properly investigate and handle out-of-specification results, often invalidating initial failures based on retesting without proper root cause. Additionally, the firm lacked adequate written procedures for process controls and failed to ensure quality unit approval for site layout designs.

## Related Documents

- [483 - 2025-08-01](https://www.globalkeysolutions.net/records/483/granules-life-sciences-private-limited/882e5d8b-bfda-4906-a5d2-38f02fb1662f)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.globalkeysolutions.net/companies/granules-life-sciences-private-limited/434955b0-03c5-4fc0-a6c2-1241872c2974

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