FDA Inspection 752925 — Morristown Medical Center Blood Bank
The FDA completed an inspection of Morristown Medical Center Blood Bank on Nov 8, 2011 in Morristown, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 8, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Morristown, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9288 | 21 CFR 640.21(a) | Eligibility of platelet donors |
| 98 | 21 CFR 606.100(c) | Thorough investigations |