FDA Inspection 833772 — Virginia Center for Reproductive Medicine
The FDA completed an inspection of Virginia Center for Reproductive Medicine on June 12, 2013 in Reston, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Biologics.
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 |