FDA Inspection 725894 — UMASS Memorial Medical Center, Inc.
The FDA completed an inspection of UMASS Memorial Medical Center, Inc. on Apr 20, 2011 in Worcester, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 20, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Worcester, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |