FDA Inspection 657948 — Donor Services Of Indiana, Inc.
The FDA completed an inspection of Donor Services Of Indiana, Inc. on Mar 29, 2010 in New Haven, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 29, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New Haven, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12232 | 21 CFR 1271.50(b)(2) | Donor testing not negative for CD agents |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12414 | 21 CFR 1271.260(d) | Corrective actions |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |