Company
United StatesUnysen Health, Inc, Mansfield, TX – FDA Inspections
Inspection records and compliance data for Unysen Health, Inc in Mansfield, Texas. 2 FDA inspections on record, 2 Form 483s, last inspected March 27, 2019.
Company Profile
This profile covers Unysen Health, Inc based in Mansfield, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected February 16, 2017. Last inspected March 27, 2019.
Most cited issue areas
- Identification procedures, Lack of or inadequate procedures1 inspection
- Quality audits - auditor independence1 inspection
- Remedial action - documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 27, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1084059 |
| February 16, 2017 | Not classified | Medical Devices & Rad Health | 1005589 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Unysen Health, Inc
FEI Number
3012239179
Address
400 Industrial Blvd Ste 104, Mansfield, Texas 76063, United States
Country
United States
ID: e39c7e39-27c0-4bd5-8d5a-bf3eaa7b6e85