FDA Inspection
Pacific Reproductive Center, Inc.Pacific Reproductive Center, Inc. – FDA Inspection, Dec 4, 2008
Record Details
This FDA Inspection record concerns Pacific Reproductive Center, Inc., with an inspection on December 4, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 4, 2008
- Product Type
- Biologics
View Company Profile
ID · 90347b8f-52b3-4667-b1d3-7b8a3d58d133
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 553351
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.85(c)Reproductive cells or tissues
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.60(a)Completion of eligibility determination
- 21 CFR 1271.50(a)Responsible person to determine, document
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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 |
| 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 |
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