FDA Inspection 708986 — Baptist Health Deaconess Madisonville Inc
The FDA completed an inspection of Baptist Health Deaconess Madisonville Inc on February 2, 2011 in Madisonville, KY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 2, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Madisonville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 255 | 21 CFR 640.31 | Donor eligibility |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 9236 | 21 CFR 630.40(b)(1) | Deferred or not eligible |
| 98 | 21 CFR 606.100(c) | Thorough investigations |