FDA Inspection 784052 — Diamond Institute for Infertility and Menopause
The FDA completed an inspection of Diamond Institute for Infertility and Menopause on May 24, 2012 in Millburn, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 24, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Millburn, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |