FDA Inspection
Regional Women's Health Group, LLCFDA Inspection 1096100 - Regional Women's Health Group, LLC - July 12, 2019
Record Details
This FDA Inspection record concerns Regional Women's Health Group, LLC, with an inspection on July 12, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 12, 2019
- Product Type
- Biologics
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ID · 0d7dbe22-70d0-463e-9159-202496f676f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096100
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
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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 |
| 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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