# FDA 483 - Scitus Pharma Services Private Limited - March 21, 2025

Source: https://www.globalkeysolutions.net/records/483/scitus-pharma-services-private-limited/ce59d5a5-acea-48e0-9628-cafb33b55bb4

> FDA 483 for Scitus Pharma Services Private Limited on March 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scitus Pharma Services Private Limited
- Inspection Date: 2025-03-21
- Product Type: drugs
- Office Name: Division of International Drug Quality
- Summary: An FDA inspection of Scitus Pharma Services Pvt., Ltd., a bioanalytical facility in Thirumudivakkam, Chennai, India, from March 17-21, 2025, revealed significant data integrity issues. The firm was cited for failing to report all relevant data, including undisclosed method validation runs and unlisted manually stopped sample analysis runs. Additionally, the inspection found inconsistencies in the application of criteria for sample reassays.

## Related Officers

- [Sylvestre K. Dossou](https://www.globalkeysolutions.net/people/sylvestre-k-dossou/962f9277-7643-4f66-add9-1c3553fa1c14)

Company: https://www.globalkeysolutions.net/companies/scitus-pharma-services-private-limited/1628fac3-34c9-462f-b6ef-02063e2a179e

Office: https://www.globalkeysolutions.net/offices/division-of-international-drug-quality/f787ba47-67be-40ca-b4c5-4b664b9c1591