FDA Inspection
Regional Women's Health Group, LLCFDA Inspection 1237108 - Regional Women's Health Group, LLC - April 29, 2024
Record Details
This FDA Inspection record concerns Regional Women's Health Group, LLC, with an inspection on April 29, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · e8b02b6f-1552-4ec2-9c34-3c62e0954ca0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237108
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
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Other FDA inspections of Regional Women's Health Group, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 12, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 19, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 11, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 4, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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