FDA Inspection
Huntington Reproductive Center Medical Group dba HRC FertilityHuntington Reproductive Center Medical Group dba HRC Fertility – FDA Inspection, Apr 26, 2018
Record Details
This FDA Inspection record concerns Huntington Reproductive Center Medical Group dba HRC Fertility, with an inspection on April 26, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 26, 2018
- Product Type
- Biologics
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ID · b0c6d0e9-a09c-45c1-82c4-ebf990636669
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049830
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
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Other FDA inspections of Huntington Reproductive Center Medical Group dba HRC Fertility
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 22, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 10, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Huntington Reproductive Center Medical Group dba HRC Fertility
- FDA Inspection 920649 - 2015-02-05
- FDA Inspection 761103 - 2011-12-22
- FDA Inspection 679893 - 2010-09-10
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