FDA Inspection
Mako Surgical CorporationMako Surgical Corporation – FDA Inspection, Aug 11, 2014
Record Details
This FDA Inspection record concerns Mako Surgical Corporation, with an inspection on August 11, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mako Surgical Corporation
- Inspection Date
- August 11, 2014
- Product Type
- Devices
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ID · bf281f75-fae1-474f-a014-2e991b729d97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891655
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(b)Analyzing service report
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Other FDA inspections of Mako Surgical Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2018 | 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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