FDA Inspection 1195117 — Colorado Center for Reproductive Medicine, LC
The FDA completed an inspection of Colorado Center for Reproductive Medicine, LC on January 20, 2023 in Virginia Beach, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 20, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Virginia Beach, VA (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 |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |