FDA Inspection
Glasir Medical, LPGlasir Medical, LP – FDA Inspection, Feb 29, 2012
Record Details
This FDA Inspection record concerns Glasir Medical, LP, with an inspection on February 29, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Glasir Medical, LP
- Inspection Date
- February 29, 2012
- Product Type
- Biologics
View Company Profile
ID · 7041f7e4-de00-4b10-a01e-10b0f7734536
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769845
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Glasir Medical, LP
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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