FDA Inspection
Mako Surgical CorporationMako Surgical Corporation – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Mako Surgical Corporation, with an inspection on February 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e387c25f-d958-48d6-ae16-fee8007f8735
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042390
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Mako Surgical Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 21, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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