FDA Inspection 1218003 — The Sperm And Embryo Bank Of New Jersey, Inc.
The FDA completed an inspection of The Sperm And Embryo Bank Of New Jersey, Inc. on Sep 5, 2023 in Mountainside, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 5, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mountainside, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 15026 | 21 CFR 1271.85(c) | Reproductive cells or tissues-cell-associated CD |