FDA Inspection 865925 — Baptist Health Deaconess Madisonville Inc
The FDA completed an inspection of Baptist Health Deaconess Madisonville Inc on Jan 31, 2014 in Madisonville, 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). 9 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Madisonville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 15033 | 21 CFR 610.47(a) | Lookback System [Collecting Establishment] |
| 15064 | 21 CFR 610.46(a) | Lookback System [Collecting Establishment] |
| 251 | 21 CFR 640.25(b) | Quality control |
| 255 | 21 CFR 640.31 | Donor eligibility |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |