FDA Inspection 920224 — Demetrius K. Lopes, M.D.
The FDA completed an inspection of Demetrius K. Lopes, M.D. on June 25, 2015 in Park Ridge, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 25, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Park Ridge, IL (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 |