833772
Virginia Center for Reproductive Medicine — FEI 3003939253
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 12, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Reston, VA (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 |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12271 | 21 CFR 1271.65(b)(2) | Prominently labeled (limited use) |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |