FDA Inspection
Demetrius K. Lopes, M.D.Demetrius K. Lopes, M.D. – FDA Inspection, Jun 25, 2015
Record Details
This FDA Inspection record concerns Demetrius K. Lopes, M.D., with an inspection on June 25, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Demetrius K. Lopes, M.D.
- Inspection Date
- June 25, 2015
- Product Type
- Devices
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ID · a0abd735-27af-4bc9-9568-528510278724
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 920224
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of control of investigational devices
- 21 CFR 50.27(a)Consent form not approved/signed/dated
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Demetrius K. Lopes, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Demetrius K. Lopes, M.D.
- FDA Inspection 1225756 - 2023-12-11
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