FDA Inspection
HRC FertilityHRC Fertility – FDA Inspection, May 27, 2010
Record Details
This FDA Inspection record concerns HRC Fertility, with an inspection on May 27, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- HRC Fertility
- Inspection Date
- May 27, 2010
- Product Type
- Biologics
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ID · e7752e11-f051-470a-a793-e7f09192e095
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663085
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.55(a)(1)Identification code affixed to container
- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.55(a)(1)Personal information included in I.D. code
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Other FDA inspections of HRC Fertility
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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