FDA Inspection 668738 — Abington Memorial Hospital
The FDA completed an inspection of Abington Memorial Hospital on Jun 14, 2010 in Abington, PA. 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Abington, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |