FDA Inspection
Compass Richmar LLCCompass Richmar LLC – FDA Inspection, Jun 28, 2012
Record Details
This FDA Inspection record concerns Compass Richmar LLC, with an inspection on June 28, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Compass Richmar LLC
- Inspection Date
- June 28, 2012
- Product Type
- Devices
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ID · fb5f0b35-77f6-451e-8816-953395684de0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 789450
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.10Failure to submit, distinct marking
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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 |
| August 24, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 741949 - 2011-08-24
- FDA Inspection 575250 - 2009-04-09
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