FDA Inspection
CNY Fertility Colorado PLLCCNY Fertility Colorado PLLC – FDA Inspection, Jan 26, 2016
Record Details
This FDA Inspection record concerns CNY Fertility Colorado PLLC, with an inspection on January 26, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CNY Fertility Colorado PLLC
- Inspection Date
- January 26, 2016
- Product Type
- Biologics
View Company Profile
ID · 77a050e4-7f17-4e1c-9098-02016ab4a3c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 980606
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.55(d)(1)Documentation maintained (general)
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of CNY Fertility Colorado PLLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 7, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 24, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 13, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 16, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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