FDA Inspection
The Sperm and Embryo Bank of New Jersey, Inc.The Sperm and Embryo Bank of New Jersey, Inc. – FDA Inspection, Sep 5, 2023
Record Details
This FDA Inspection record concerns The Sperm and Embryo Bank of New Jersey, Inc., with an inspection on September 5, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 5, 2023
- Product Type
- Biologics
View Company Profile
ID · 9cb65c11-d698-4728-9660-c2a7425b32ce
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1218003
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.85(c)Reproductive cells or tissues-cell-associated CD
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Other FDA inspections of The Sperm and Embryo Bank of New Jersey, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2025 | NAI | New Jersey District Office | Blood and Blood Products |
| November 12, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 10, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 19, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 14, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for The Sperm and Embryo Bank of New Jersey, Inc.
- FDA Inspection 1264885 - 2025-03-26
- FDA Inspection 1111192 - 2019-11-12
- FDA Inspection 1058722 - 2018-07-10
- FDA Inspection 985821 - 2016-08-19
- FDA Inspection 855714 - 2013-11-14
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