FDA Inspection 1162967 — Diamond Institute for Infertility and Menopause
The FDA completed an inspection of Diamond Institute for Infertility and Menopause on February 23, 2022 in Millburn, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 23, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Millburn, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12255 | 21 CFR 1271.60(c) | Shipped but not kept in quarantine |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |