FDA Inspection 917307 — Baptist Health Hardin
The FDA completed an inspection of Baptist Health Hardin on Mar 3, 2015 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). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 3, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Elizabethtown, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 114 | 21 CFR 606.121(c)(1) | Proper name of product |
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 143 | 21 CFR 606.140(b) | Provisions to monitor lab test procedures & instruments |
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |
| 98 | 21 CFR 606.100(c) | Thorough investigations |