FDA Inspection 744753 — Baystate Medical Center, Inc.
The FDA completed an inspection of Baystate Medical Center, Inc. on August 19, 2011 in Springfield, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Springfield, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |