FDA Inspection 1041651 — Lee Memorial Health System
The FDA completed an inspection of Lee Memorial Health System on February 9, 2018 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18096 | 21 CFR 630.10(g)(2)(ii) | Donor's Acknowledgment - Exculpatory language |
| 9243 | 21 CFR 630.40(a) | Notification |