Company
United StatesVortran Medical Technology 1, Inc, Sacramento, CA – FDA Inspections
Inspection records and compliance data for Vortran Medical Technology 1, Inc in Sacramento, California. 4 FDA inspections on record, 1 Form 483, last inspected July 17, 2024.
Company Profile
This profile covers Vortran Medical Technology 1, Inc based in Sacramento, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 26, 2009. Last inspected July 17, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 17, 2024 | Not classified | Medical Devices & Rad Health | 1246791 |
| April 11, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1010791 |
| May 29, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 834679 |
| February 26, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 566225 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Vortran Medical Technology 1, Inc
FEI Number
1000307109
Address
21 Golden Land Ct Ste 100, Sacramento, California 95834, United States
Country
United States
ID: 15e4ac0e-b666-4e83-a621-32103775cbdf