FDA Inspection 1148280 — Lee Memorial Health System
The FDA completed an inspection of Lee Memorial Health System on August 6, 2021 in Fort Myers, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 6, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |
| 9235 | 21 CFR 630.40(c) | Documentation |
| 9236 | 21 CFR 630.40(b)(1) | Deferred or not eligible |
| 9243 | 21 CFR 630.40(a) | Notification |