# FDA 483 - Amitabha Mazumder, M.D. - April 05, 2024

Source: https://www.keypedia.com/records/483/amitabha-mazumder-md/5b1206b6-1430-4426-a304-bc0dd7b81391

> FDA 483 for Amitabha Mazumder, M.D. on April 05, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amitabha Mazumder, M.D.
- Inspection Date: 2024-04-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Clinical Investigator Amitabha (NMI) Mazumder in Pasadena, CA, and issued a Form 483 for significant deviations from an investigational plan. Observations included failures to perform required hematocrit level assessments, administer study drug without prior testing, administer protocol-prohibited medication, and properly assess patient reported outcomes. These findings indicate serious non-compliance with the study protocol.

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Company: https://www.keypedia.com/companies/amitabha-mazumder-md/cf6e20fc-a241-490a-96ec-954dea17b9e7

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6