# FDA 483 - Satyaprakash N. Makam, MD - September 22, 2011

Source: https://www.keypedia.com/records/483/satyaprakash-n-makam-md/fc7226ab-3f32-4a53-b020-79354017d760

> FDA 483 for Satyaprakash N. Makam, MD on September 22, 2011. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Satyaprakash N. Makam, MD
- Inspection Date: 2011-09-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Satyaprakash N. Makam, MD, a clinical investigator in Munster, IN, was inspected by the FDA, revealing significant deficiencies in clinical study conduct. The inspection cited issues primarily related to informed consent procedures, adherence to the investigational plan, and control of investigational devices. These violations indicate a failure to ensure subject protection and data integrity during the study.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/neali-h-lucas/2f08b1c2-8a68-4785-a587-0112e54f6774)

Company: https://www.keypedia.com/companies/satyaprakash-n-makam-md/760d267a-7bf4-4ddb-b051-1413bbfc03a5

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0