FDA Inspection
CryoGam Colorado, LLC.CryoGam Colorado, LLC. – FDA Inspection, Nov 19, 2008
Record Details
This FDA Inspection record concerns CryoGam Colorado, LLC., with an inspection on November 19, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CryoGam Colorado, LLC.
- Inspection Date
- November 19, 2008
- Product Type
- Biologics
View Company Profile
ID · 133e4bff-d75f-451d-8fc0-d3a57847252d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 549490
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.60(b)Identified as quarantined, distinguishable
- 21 CFR 1271.60(a)Semen retesting quarantine
- 21 CFR 1271.75(e)Abbreviated procedure
- 21 CFR 1271.50(a)Responsible person to determine, document
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 |
| July 28, 2017 | VAI | 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 |
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 1019771 - 2017-07-28
- FDA Inspection 807027 - 2012-11-05
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