FDA Inspection
Reproductive Health Associates, Inc.Reproductive Health Associates, Inc. – FDA Inspection, May 1, 2012
Record Details
This FDA Inspection record concerns Reproductive Health Associates, Inc., with an inspection on May 1, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 1, 2012
- Product Type
- Biologics
View Company Profile
ID · 296dd110-5dd5-4257-9571-be8e52906c66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 778998
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Reproductive Health Associates, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 30, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 6, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Reproductive Health Associates, Inc.
- FDA Inspection 980255 - 2016-03-09
- FDA Inspection 888908 - 2014-07-30
- FDA Inspection 602338 - 2009-08-06
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