FDA Inspection 676607 — Lee Memorial Health System IRC
The FDA completed an inspection of Lee Memorial Health System IRC on Aug 20, 2010 in Cape Coral, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 20, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Cape Coral, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |