FDA Inspection
Regional Women's Health Group, LLCFDA Inspection 904835 - Regional Women's Health Group, LLC - November 19, 2014
Record Details
This FDA Inspection record concerns Regional Women's Health Group, LLC, with an inspection on November 19, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 19, 2014
- Product Type
- Biologics
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ID · ebaac7f5-c9ac-4515-9f0c-5e22342a3f03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 904835
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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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 |
| 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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