Company
United StatesMako Surgical Corporation, Weston, FL – FDA Inspections
Inspection records and compliance data for Mako Surgical Corporation in Weston, Florida. 3 FDA inspections on record, 1 Form 483, last inspected February 23, 2018.
Company Profile
This profile covers Mako Surgical Corporation based in Weston, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected January 21, 2009. Last inspected February 23, 2018.
Most cited issue areas
- Documentation2 inspections
- Analyzing service report1 inspection
- CAPA verification/validation of corrective/preventive action1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 23, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1042390 |
| August 11, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 891655 |
| January 21, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 558670 |
FDA documents
Form 483s (1)
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Company Information
Name
Mako Surgical Corporation
FEI Number
3005985723
Address
3365 Enterprise Ave, Weston, Florida 33331, United States
Country
United States
ID: b3dee03a-730e-4f79-855f-f0d128e4dd0f