# FDA 483 - Naseem A. Jaffrani, M.D. - March 13, 2025

Source: https://www.keypedia.com/records/483/naseem-a-jaffrani-md/2131b5ce-2494-4de0-8724-a136e9945fbd

> FDA 483 for Naseem A. Jaffrani, M.D. on March 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Naseem A. Jaffrani, M.D.
- Inspection Date: 2025-03-13
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Naseem A. Jaffrani MD, Clinical Investigator, revealed significant non-compliance in clinical research studies. The firm failed to promptly report serious and non-serious adverse events, did not conduct investigations according to the plan, and maintained inadequate and inaccurate case histories. Additional deficiencies included improper informed consent documentation, unapproved changes by the Institutional Review Board, and insufficient investigational drug disposition records.

## Related Documents

- [WARNING_LETTER - 2025-03-13](https://www.keypedia.com/records/warning_letter/naseem-a-jaffrani-md/58d8eff2-f8df-446f-9a83-6226bf49abac)

## Related Officers

- [Christopher M. Jeffers](https://www.keypedia.com/people/christopher-m-jeffers/327faaff-619a-4180-ab4c-b5f1b5ba84be)

Company: https://www.keypedia.com/companies/naseem-a-jaffrani-md/ec3be6c6-541c-4502-89ad-9e29271cfad1

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea