FDA Inspection 810741 — Baptist Health Hardin
The FDA completed an inspection of Baptist Health Hardin on Dec 13, 2012 in Elizabethtown, KY. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Elizabethtown, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 167 | 21 CFR 606.170(b) | Adverse reaction - fatality |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |