FDA Inspection
Columbia Scientific Development LLCColumbia Scientific Development LLC – FDA Inspection, Jun 7, 2017
Record Details
This FDA Inspection record concerns Columbia Scientific Development LLC, with an inspection on June 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d20a9694-0ef6-47b8-bff6-c06fe6677fe6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013301
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Columbia Scientific Development LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 18, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Columbia Scientific Development LLC
- FDA Inspection 973833 - 2016-05-18
- FDA Inspection 973831 - 2016-05-18
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