FDA Inspection
Women's Health ConsultantsWomen's Health Consultants – FDA Inspection, Sep 24, 2012
Record Details
This FDA Inspection record concerns Women's Health Consultants, with an inspection on September 24, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Women's Health Consultants
- Inspection Date
- September 24, 2012
- Product Type
- Biologics
View Company Profile
ID · dc4eed4b-64b8-4084-94a2-7e7d94e2a501
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 800631
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Women's Health Consultants
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 13, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 1, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 7, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Women's Health Consultants
- FDA Inspection 1039910 - 2017-12-15
- FDA Inspection 951015 - 2015-10-13
- FDA Inspection 702663 - 2010-11-01
- FDA Inspection 582132 - 2009-04-07
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