827487
Columbia Fertility Associates, LLC — FEI 3003937470
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 16, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Washington, DC (United States)
Citations
| ID | CFR | Description |
|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |