FDA Inspection 636071 — New Life Generation, Inc.
The FDA completed an inspection of New Life Generation, Inc. on December 23, 2009 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 23, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |