FDA Inspection 1084676 — Foulk & Whitten Nevada Center For Reproductive Medicine
The FDA completed an inspection of Foulk & Whitten Nevada Center For Reproductive Medicine on March 28, 2019 in Reno, NV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 28, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Reno, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |