FDA Inspection
HRC FertilityHRC Fertility – FDA Inspection, Mar 21, 2014
Record Details
This FDA Inspection record concerns HRC Fertility, with an inspection on March 21, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- HRC Fertility
- Inspection Date
- March 21, 2014
- Product Type
- Biologics
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ID · 6d2d2256-5cc8-4fb9-bf71-d657160cf2e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 871113
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.47(c)Availability of procedures
- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HRC Fertility
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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