FDA Inspection
Cryos International USA, LLCCryos International USA, LLC – FDA Inspection, Jul 15, 2015
Record Details
This FDA Inspection record concerns Cryos International USA, LLC, with an inspection on July 15, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Cryos International USA, LLC
- Inspection Date
- July 15, 2015
- Product Type
- Biologics
View Company Profile
ID · 4afb14b1-86bf-45cb-9995-13d56778371d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 934491
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.80(b)Specimen collections not timely
- 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 Cryos International USA, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2025 | Not classified | Florida District Office | |
| June 22, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 8, 2022 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 3, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 14, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Cryos International USA, LLC
- FDA Inspection 1262877 - 2025-02-28
- FDA Inspection 1209242 - 2023-06-22
- FDA Inspection 1164424 - 2022-03-08
- FDA Inspection 1088826 - 2019-04-03
- FDA Inspection 1021574 - 2017-03-14
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