1147606
SpringCreek Fertility — FEI 3011408185
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 2, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Centerville, OH (United States)
Citations
| ID | CFR | Description |
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |