FDA Inspection
Barnett International CorporationBarnett International Corporation – FDA Inspection, Aug 23, 2013
Record Details
This FDA Inspection record concerns Barnett International Corporation, with an inspection on August 23, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 23, 2013
- Product Type
- Devices
View Company Profile
ID · 2a816cd0-c3b7-4f0d-a056-e82ff96628eb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 844630
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Barnett International Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2026 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 8, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 4, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Barnett International Corporation
- FDA Inspection 1328626 - 2026-07-30
- FDA Inspection 1217755 - 2023-08-08
- FDA Inspection 942423 - 2015-09-14
- FDA Inspection 685523 - 2010-08-04
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