FDA Inspection
Regional Women's Health Group, LLCFDA Inspection 840142 - Regional Women's Health Group, LLC - July 11, 2013
Record Details
This FDA Inspection record concerns Regional Women's Health Group, LLC, with an inspection on July 11, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 11, 2013
- Product Type
- Biologics
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ID · 623c2da7-5f36-49dd-8dff-53ade198272c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840142
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.90(c)Eligibility not required--warning labels
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Other FDA inspections of Regional Women's Health Group, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 |
| March 4, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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