FDA Inspection
GEXPRO, a Division of REXEL USA IncGEXPRO, a Division of REXEL USA Inc – FDA Inspection, Oct 12, 2010
Record Details
This FDA Inspection record concerns GEXPRO, a Division of REXEL USA Inc, with an inspection on October 12, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 12, 2010
- Product Type
- Devices
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ID · 59c7db5e-293b-4cb8-a43d-f1f7919652d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 684651
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of GEXPRO, a Division of REXEL USA Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2024 | Not classified | Minneapolis District Office | |
| February 14, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 25, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 26, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GEXPRO, a Division of REXEL USA Inc
- FDA Inspection 1252511 - 2024-09-23
- FDA Inspection 1120075 - 2020-02-14
- FDA Inspection 949230 - 2015-09-25
- FDA Inspection 742200 - 2011-08-26
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