FDA Inspection 747956 — Satyaprakash N. Makam, MD
The FDA completed an inspection of Satyaprakash N. Makam, MD on September 22, 2011 in Munster, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Munster, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 7012 | 21 CFR 812.100 | Investigator lack of control of investigational devices |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |