FDA Inspection 739932 — New Life Generation, Inc.
The FDA completed an inspection of New Life Generation, Inc. on August 10, 2011 in Indianapolis, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 10, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12257 | 21 CFR 1271.60(c)(2) | Records stating determination not completed |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |
| 12458 | 21 CFR 1271.320(b) | Designated complaint file |