FDA Inspection 809990 — Delaware Valley Institute Of Fertility & Genetics
The FDA completed an inspection of Delaware Valley Institute Of Fertility & Genetics on Dec 6, 2012 in Marlton, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 6, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Marlton, NJ (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 |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |