FDA Inspection 769928 — New Life Generation, Inc.
The FDA completed an inspection of New Life Generation, Inc. on February 28, 2012 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |