FDA Inspection 1204620 — Amy Lightner MD
The FDA completed an inspection of Amy Lightner MD on Apr 26, 2023 in Cleveland, OH. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 26, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Cleveland, OH (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 22727 | 21 CFR 312.64(b) | Safety Reports - Serious Events |
| 22728 | 21 CFR 312.64(b) | Safety Reports - Non-Serious Events |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7558 | 21 CFR 312.57(c) | Record retention requirement |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |