FDA Inspection 711830 — Center For Fertility And Reproductive Endocrinology UPP
The FDA completed an inspection of Center For Fertility And Reproductive Endocrinology UPP on Feb 23, 2011 in Pittsburgh, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 23, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |