FDA Inspection
Arthomed, LLC.Arthomed, LLC. – FDA Inspection, Apr 1, 2014
Record Details
This FDA Inspection record concerns Arthomed, LLC., with an inspection on April 1, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Arthomed, LLC.
- Inspection Date
- April 1, 2014
- Product Type
- Biologics
View Company Profile
ID · 8ea701da-70b0-40a4-8520-9521b528e0e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 872590
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Arthomed, LLC.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 22, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 26, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 19, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Arthomed, LLC.
- FDA Inspection 1195570 - 2023-01-25
- FDA Inspection 1081409 - 2019-02-22
- FDA Inspection 971857 - 2016-04-26
- FDA Inspection 590672 - 2009-06-19
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