# FDA 483 - Rajendra R. Makkar, MD - August 05, 2019

Source: https://www.keypedia.com/records/483/rajendra-r-makkar-md/4c5cd55e-fc9d-470a-a4d8-9a7b14f9edc9

> FDA 483 for Rajendra R. Makkar, MD on August 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rajendra R. Makkar, MD
- Inspection Date: 2019-08-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Rajendra R. Makkar, MD in Los Angeles, CA, revealed significant deviations from a clinical investigational plan. The firm failed to adhere to the study protocol, leading to issues with screening procedures, required laboratory assessments, and timely reporting of adverse events. These failures were observed across multiple subjects, indicating a systemic lack of compliance with the agreed-upon clinical protocol.

## Related Officers

- [investigator](https://www.keypedia.com/people/angela-shepas/743113c1-799b-44e9-9422-8049c476bfd2)

Company: https://www.keypedia.com/companies/rajendra-r-makkar-md/9bc82c8e-f40e-416b-af12-93d21d5cf458

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