FDA Inspection 781227 — Family Beginnings, PC
The FDA completed an inspection of Family Beginnings, PC on May 8, 2012 in Indianapolis, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 8, 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 |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |