FDA Inspection
Mako Surgical CorporationMako Surgical Corporation – FDA Inspection, Jan 21, 2009
Record Details
This FDA Inspection record concerns Mako Surgical Corporation, with an inspection on January 21, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mako Surgical Corporation
- Inspection Date
- January 21, 2009
- Product Type
- Devices
View Company Profile
ID · d221529c-5d05-485b-8cc6-39e09f453f1a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 558670
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
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 |
| August 11, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mako Surgical Corporation
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.