FDA Inspection 645186 — IVF Phoenix P.L.L.C.
The FDA completed an inspection of IVF Phoenix P.L.L.C. on February 5, 2010 in Scottsdale, AZ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 5, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12225 | 21 CFR 1271.47(d) | Departures: recording and justifying |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |