FDA Inspection
Hinsdale Center for ReproductionHinsdale Center for Reproduction – FDA Inspection, Feb 12, 2014
Record Details
This FDA Inspection record concerns Hinsdale Center for Reproduction, with an inspection on February 12, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 12, 2014
- Product Type
- Biologics
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ID · 1a0f6051-f1fd-479c-a711-4907f5cbc73c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866254
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.50(a)Determination based on screening and testing
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Other FDA inspections of Hinsdale Center for Reproduction
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 10, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 22, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Hinsdale Center for Reproduction
- FDA Inspection 1081739 - 2018-12-20
- FDA Inspection 998563 - 2017-01-10
- FDA Inspection 715664 - 2011-03-22
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