# FDA 483 - Raptim Research Pvt. Ltd. - April 24, 2023

Source: https://www.globalkeysolutions.net/records/483/raptim-research-pvt-ltd/2d6ad079-7dca-492c-bb02-f60d75c4546a

> FDA 483 for Raptim Research Pvt. Ltd. on April 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Raptim Research Pvt. Ltd.
- Inspection Date: 2023-04-24
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Raptim Research Private Limited, a Contract Research Organization in Navi Mumbai, India, was cited for significant deficiencies in its bioanalytical studies. Observations included unjustified rejection and repetition of analytical runs, improper calculation of internal standard peak areas, and inadequate accountability of biological samples. The firm also failed to contemporaneously document investigations and include all relevant data in method validation statistics, indicating serious data integrity and quality control issues.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kara-a-scheibner/63643a3f-4a8e-4dcc-8f1a-6fcf98519aad)
- [Hasan A. Irier](https://www.globalkeysolutions.net/people/hasan-a-irier/8757c2d5-77b0-45a7-b0f2-e42ef3ee306f)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321