FDA Inspection 1040654 — Foulk Nevada Fertility Center, PC
The FDA completed an inspection of Foulk Nevada Fertility Center, PC on February 1, 2018 in Las Vegas, NV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 1, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Las Vegas, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12235 | 21 CFR 1271.55(a)(1) | Personal information included in I.D. code |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12257 | 21 CFR 1271.60(c)(2) | Records stating determination not completed |
| 12258 | 21 CFR 1271.60(c)(3) | Statement of restrictions |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |