# FDA 483 - Naveed Razzaque, MD - September 25, 2019

Source: https://www.keypedia.com/records/483/naveed-razzaque-md/e805765c-ef49-4ada-b9d7-260111638b13

> FDA 483 for Naveed Razzaque, MD on September 25, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Naveed Razzaque, MD
- Inspection Date: 2019-09-25
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Naveed Razzaque, MD in Bridgeton, MO, revealed critical deficiencies in clinical trial conduct. The firm failed to maintain adequate and accurate case histories, including instances of falsified records and forged signatures, which severely compromised data integrity. Additionally, the investigation found a lack of proper oversight, leading to missed protocol procedures and significant delays in reporting adverse events and protocol deviations to the IRB, raising concerns about subject safety and study validity.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/karen-m-montgomery/ee91b1bb-8d51-4fdc-bee5-949441136e59)

Company: https://www.keypedia.com/companies/naveed-razzaque-md/2269dc7e-e144-4697-b333-a961db6a1893

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8