FDA Inspection
CNY Fertility Colorado PLLCCNY Fertility Colorado PLLC – FDA Inspection, Apr 24, 2013
Record Details
This FDA Inspection record concerns CNY Fertility Colorado PLLC, with an inspection on April 24, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CNY Fertility Colorado PLLC
- Inspection Date
- April 24, 2013
- Product Type
- Biologics
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ID · ad145253-b7ef-477d-93cf-b140c525f8f2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 828995
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
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 |
| January 26, 2016 | 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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