FDA Inspection 557242 — McLaughlin, Vallerie, MD
The FDA completed an inspection of McLaughlin, Vallerie, MD on Jan 7, 2009 in Ann Arbor, MI. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 7, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Ann Arbor, MI (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7488 | 21 CFR 312.59 | Records of unused drug disposition |
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 7520 | 21 CFR 312.64(b) | Safety reports |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |