FDA Inspection
North Carolina Center for Reproductive Medicine Inc (NCCRM)North Carolina Center for Reproductive Medicine Inc (NCCRM) – FDA Inspection, Feb 6, 2018
Record Details
This FDA Inspection record concerns North Carolina Center for Reproductive Medicine Inc (NCCRM), with an inspection on February 6, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 6, 2018
- Product Type
- Biologics
View Company Profile
ID · 863d4e38-753a-49c0-a23d-123894d56594
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040135
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.85(a)Infection with communicable disease agents
Full citation text and observation details available on the Dashboard.
Other FDA inspections of North Carolina Center for Reproductive Medicine Inc (NCCRM)
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 26, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 16, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 5, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 11, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for North Carolina Center for Reproductive Medicine Inc (NCCRM)
- FDA Inspection 1259321 - 2025-01-22
- FDA Inspection 1195608 - 2023-01-26
- FDA Inspection 1121058 - 2020-03-16
- FDA Inspection 968307 - 2016-05-05
- FDA Inspection 886807 - 2014-07-11
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