FDA Inspection
Barton-Carey Medical Products IncBarton-Carey Medical Products Inc – FDA Inspection, Aug 10, 2012
Record Details
This FDA Inspection record concerns Barton-Carey Medical Products Inc, with an inspection on August 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 10, 2012
- Product Type
- Devices
View Company Profile
ID · 9171957a-db6b-4adc-b1a5-ffc12fd36a5e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 797568
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Barton-Carey Medical Products Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 4, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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