FDA Inspection
Pacific Reproductive Center, Inc.Pacific Reproductive Center, Inc. – FDA Inspection, Jul 6, 2015
Record Details
This FDA Inspection record concerns Pacific Reproductive Center, Inc., with an inspection on July 6, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 6, 2015
- Product Type
- Biologics
View Company Profile
ID · 8f672129-cfab-49c2-a6a8-eba83bb0f5a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 933297
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pacific Reproductive Center, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 31, 2023 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 15, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 18, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 3, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Pacific Reproductive Center, Inc.
- FDA Inspection 1247061 - 2024-08-19
- FDA Inspection 1216495 - 2023-08-31
- FDA Inspection 1041285 - 2018-02-15
- FDA Inspection 810928 - 2012-12-18
- FDA Inspection 722575 - 2011-05-03
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