# FDA 483 - DESANO PHARMACEUTICALS PRIVATE LIMITED - June 06, 2025

Source: https://www.keypedia.com/records/483/desano-pharmaceuticals-private-limited/f6d23a8a-738c-4f55-8d13-f8bc49973f4e

> FDA 483 for DESANO PHARMACEUTICALS PRIVATE LIMITED on June 06, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DESANO PHARMACEUTICALS PRIVATE LIMITED
- Inspection Date: 2025-06-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Desano Pharmaceuticals Private Limited in Bengaluru, India, received a Form 483 with four observations during an FDA inspection. The firm was cited for deficiencies in batch production and control records, inadequate procedures for preventing objectionable microorganisms in non-sterile drug products, failure to follow written procedures for component qualification, and insufficient assurance of data backup integrity. These issues highlight significant concerns regarding quality control, environmental monitoring, vendor management, and data management practices.

## Related Officers

- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.keypedia.com/companies/desano-pharmaceuticals-private-limited/80efa9c2-c781-4527-b106-92193d41ee32

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