FDA Inspection 805303 — Family Beginnings, PC
The FDA completed an inspection of Family Beginnings, PC on October 25, 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12224 | 21 CFR 1271.47(c) | Availability of procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12270 | 21 CFR 1271.65(a) | Improper release prevention--storage, I.D. |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |