FDA Inspection 944907 — Munroe Regional Medical Center Clinical Laboratory
The FDA completed an inspection of Munroe Regional Medical Center Clinical Laboratory on Oct 2, 2015 in Ocala, 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 2, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Ocala, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |