FDA Inspection
Wright Medical Technology IncWright Medical Technology Inc – FDA Inspection, Mar 21, 2013
Record Details
This FDA Inspection record concerns Wright Medical Technology Inc, with an inspection on March 21, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 21, 2013
- Product Type
- Biologics
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ID · 841d5bba-6e16-418b-8df2-0e3f48e23cdf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 824106
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.260(d)Corrective actions
- 21 CFR 1271.195(a)Adequate control, proper conditions
- 21 CFR 1271.170(b)Qualifications lacking
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Wright Medical Technology Inc
11| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2024 | Not classified | New Orleans District Office | |
| September 29, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 8, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 30, 2017 | Not classified | New Orleans District Office | |
| April 13, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Wright Medical Technology Inc
- FDA Inspection 1250121 - 2024-09-10
- FDA Inspection 1153158 - 2021-09-29
- FDA Inspection 1102019 - 2019-08-08
- FDA Inspection 1053483 - 2017-11-30
- FDA Inspection 1010322 - 2017-04-13
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