# FDA 483 - Raptim Research Pvt. Ltd. - July 25, 2025

Source: https://www.globalkeysolutions.net/records/483/raptim-research-pvt-ltd/9a59b441-19a3-4c46-9f3e-474767219e35

> FDA 483 for Raptim Research Pvt. Ltd. on July 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Raptim Research Pvt. Ltd.
- Inspection Date: 2025-07-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Raptim Research Private Limited, a Contract Research Organization in Navi Mumbai, India, revealed significant deficiencies across multiple areas. The firm failed to adhere to its own standard operating procedures, maintained inadequate documentation for study reconstruction, and demonstrated inconsistent practices. Additionally, issues with raw data management and computer system backups were identified, indicating systemic control failures.

## Related Documents

- [483 - 2023-04-24](https://www.globalkeysolutions.net/records/483/raptim-research-pvt-ltd/2d6ad079-7dca-492c-bb02-f60d75c4546a)

## Related Officers

- [Arindam Dasgupta, Ph.D., Div. Director (Acting)](https://www.globalkeysolutions.net/people/arindam-dasgupta-phd-div-director-acting/a8348132-0b97-4bec-bfd9-e1cbc7fa37c8)
- [Courtney N. Long, Investigator](https://www.globalkeysolutions.net/people/courtney-n-long-investigator/0d1ea4e9-f349-43f5-a536-7e0686374010)
- [Melkamu Getie-Kebtie PhD, RPh, Pharmacologist](https://www.globalkeysolutions.net/people/melkamu-getie-kebtie-phd-rph-pharmacologist/614a1bb2-1046-48db-b151-3207116a1fe0)
- [Kara A. Scheibner, Ph.D., Pharmacologist](https://www.globalkeysolutions.net/people/kara-a-scheibner-phd-pharmacologist/f1cc551d-94cd-482d-926a-f3826989fd34)
- [issuing_officer](https://www.globalkeysolutions.net/people/kara-a-scheibner/63643a3f-4a8e-4dcc-8f1a-6fcf98519aad)

Company: https://www.globalkeysolutions.net/companies/raptim-research-pvt-ltd/e9b524cf-a459-4a4d-9ac3-2198443949e2

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