FDA Inspection
CryoGam Colorado, LLC.CryoGam Colorado, LLC. – FDA Inspection, Jul 28, 2017
Record Details
This FDA Inspection record concerns CryoGam Colorado, LLC., with an inspection on July 28, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 978c50e9-a67f-4236-b7c3-2d54f280b29f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019771
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CryoGam Colorado, LLC.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 23, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 10, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 15, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 5, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 24, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for CryoGam Colorado, LLC.
- FDA Inspection 1277817 - 2025-07-23
- FDA Inspection 1195173 - 2023-01-10
- FDA Inspection 1063939 - 2018-08-15
- FDA Inspection 807027 - 2012-11-05
- FDA Inspection 726307 - 2011-05-24
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