FDA Inspection
Pacific Reproductive Center, Inc.Pacific Reproductive Center, Inc. – FDA Inspection, Feb 15, 2018
Record Details
This FDA Inspection record concerns Pacific Reproductive Center, Inc., with an inspection on February 15, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · fc6aa3c2-98fd-4e64-9058-5aeaf6a662a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041285
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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 |
| July 6, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 933297 - 2015-07-06
- FDA Inspection 810928 - 2012-12-18
- FDA Inspection 722575 - 2011-05-03
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