1115747
Montgomery Fertility Center — FEI 3009658676
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 21, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |