FDA Inspection 556025 — Baptist Health Deaconess Madisonville Inc
The FDA completed an inspection of Baptist Health Deaconess Madisonville Inc on December 18, 2008 in Madisonville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Madisonville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 251 | 21 CFR 640.25(b) | Quality control |
| 253 | 21 CFR 640.25(b)(4) | Corrective action |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 75 | 21 CFR 606.100(a) | SOP compliance |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |