FDA Inspection
Women for Women Medical Associates, LLCWomen for Women Medical Associates, LLC – FDA Inspection, Jun 11, 2014
Record Details
This FDA Inspection record concerns Women for Women Medical Associates, LLC, with an inspection on June 11, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 11, 2014
- Product Type
- Biologics
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ID · 38218364-5061-46b2-ad18-2a96e76b7307
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 881095
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Women for Women Medical Associates, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 27, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 12, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 31, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Women for Women Medical Associates, LLC
- FDA Inspection 1249075 - 2024-08-26
- FDA Inspection 1177563 - 2022-07-27
- FDA Inspection 1074898 - 2018-12-12
- FDA Inspection 984039 - 2016-08-31
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