FDA Inspection 844021 — New England Donor Services, Inc.
The FDA completed an inspection of New England Donor Services, Inc. on August 1, 2013 in Waltham, 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) (VAI)
- End Date
- August 1, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Waltham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |