FDA Inspection 979157 — Diamond Institute for Infertility and Menopause
The FDA completed an inspection of Diamond Institute for Infertility and Menopause on July 6, 2016 in Millburn, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 6, 2016
- Fiscal Year
- 2016
- 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 |
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12275 | 21 CFR 1271.65(c) | Nonclinical use--label requirements |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |