FDA Inspection 696247 — New England Donor Services, Inc.
The FDA completed an inspection of New England Donor Services, Inc. on October 15, 2010 in Waltham, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 15, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Waltham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12353 | 21 CFR 1271.190(d)(1) | Description of methods, schedule |