FDA Inspection 559583 — Gordon, Mark, M.D.
The FDA completed an inspection of Gordon, Mark, M.D. on Jan 29, 2009 in New Hyde Park, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New Hyde Park, NY (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7543 | 21 CFR 312.61 | Unauthorized recipients (investigator) |