Company
United StatesVivax Medical Corp., Naugatuck, CT – FDA Inspections
Inspection records and compliance data for Vivax Medical Corp. in Naugatuck, Connecticut. 5 FDA inspections on record, last inspected April 17, 2024.
Company Profile
This profile covers Vivax Medical Corp. based in Naugatuck, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected August 11, 2011. Last inspected April 17, 2024.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design control - no procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 17, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1236380 |
| January 8, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1115081 |
| July 14, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1018730 |
| March 26, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 871555 |
| August 11, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 740132 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Vivax Medical Corp.
FEI Number
1000513669
Address
54 Great Hill Rd, Naugatuck, Connecticut 06770, United States
Country
United States
ID: 41561001-4174-4f59-aa07-c76f5ca43f5c