# FDA 483 - Granules Life Sciences Pvt. Ltd. - August 01, 2025

Source: https://www.keypedia.com/records/483/granules-life-sciences-pvt-ltd/9a62e127-0235-4ac8-8e37-5b74cf6aaf6c

> FDA 483 for Granules Life Sciences Pvt. Ltd. on August 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Granules Life Sciences Pvt. Ltd.
- Inspection Date: 2025-08-01
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: During an inspection conducted by the U.S. Food and Drug Administration (FDA) from July 28 to August 1, 2025, Granules Life Sciences Pvt. Ltd., a drug manufacturing facility located in Medchal-Malkajgiri District, Telangana, India, received a Form FDA 483. The primary observation cited a lack of appropriate controls over computer and related systems, failing to ensure that changes to master production, control, and other critical records are instituted only by authorized personnel. Investigators noted several specific issues, including the use of shared usernames and passwords for various Human Machine Interface (HMI) systems and laboratory testing equipment, which are used in manufacturing drug products for the U.S. market. Additionally, systems allowed alarm acknowledgments without proper sign-in, and in-process testing equipment permitted operators to overwrite previous results and alter program parameters. Critical laboratory instruments, such as scales, balances, and analytical equipment used for material and product testing, lacked individual username privileges and password protection. These findings indicate deficiencies in data integrity and system security, which are essential under drug manufacturing regulations. Granules Life Sciences Pvt. Ltd. is required to assess these observations and implement effective corrective actions to resolve the identified control lapses.

## Related Officers

- [Lori B. Wilkstrom](https://www.keypedia.com/people/lori-b-wilkstrom/541f4a17-d0d3-4a8e-a105-13f18c8bc4c4)

Company: https://www.keypedia.com/companies/granules-life-sciences-pvt-ltd/23c0af8b-6f3d-4213-a3de-1254edd39d1e

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