Company
United StatesGalix Biomedical Instrumentation, Inc., Doral, FL – FDA Inspections
Inspection records and compliance data for Galix Biomedical Instrumentation, Inc. in Doral, Florida. 3 FDA inspections on record, 1 Form 483, last inspected July 03, 2017.
Company Profile
This profile covers Galix Biomedical Instrumentation, Inc. based in Doral, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected September 21, 2009. Last inspected July 3, 2017.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ2 inspections
- Lack of or inadequate final acceptance procedures2 inspections
- Design control - no procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 3, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1016788 |
| May 21, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 832712 |
| September 21, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 615917 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Galix Biomedical Instrumentation, Inc.
FEI Number
3001673090
Address
8205 Nw 30th Ter, Doral, Florida 33122, United States
Country
United States
ID: 2ead02e9-31cf-4027-b904-dd137af1b7e0