FDA Inspection
Regional Womens Health Group LLCRegional Womens Health Group LLC – FDA Inspection, Feb 20, 2013
Record Details
This FDA Inspection record concerns Regional Womens Health Group LLC, with an inspection on February 20, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 20, 2013
- Product Type
- Biologics
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ID · 6fb44734-3c45-4465-ba4b-6e4cb5e1d5fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 819345
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.50(a)Determination based on screening and testing
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Other FDA inspections of Regional Womens Health Group LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2026 | Not classified | New Jersey District Office | |
| February 21, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 17, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 15, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 1, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Regional Womens Health Group LLC
- FDA Inspection 1303160 - 2026-02-11
- FDA Inspection 1198760 - 2023-02-21
- FDA Inspection 1102414 - 2019-09-17
- FDA Inspection 1003951 - 2017-02-15
- FDA Inspection 929318 - 2015-06-01
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