FDA Inspection
Compass Richmar LLCCompass Richmar LLC – FDA Inspection, Aug 24, 2011
Record Details
This FDA Inspection record concerns Compass Richmar LLC, with an inspection on August 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Compass Richmar LLC
- Inspection Date
- August 24, 2011
- Product Type
- Devices
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ID · a07906ac-ea5f-4b9f-a7e9-ac3edad440e4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 741949
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
16- 21 CFR 820.80(e)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
Showing 10 of 16 citations.
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Other FDA inspections of Compass Richmar LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 30, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 28, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 9, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Compass Richmar LLC
- FDA Inspection 982331 - 2016-07-14
- FDA Inspection 889077 - 2014-07-30
- FDA Inspection 789450 - 2012-06-28
- FDA Inspection 575250 - 2009-04-09
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