Company
TaiwanWellell Inc, New Taipei City, Taiwan – FDA Inspections
Inspection records and compliance data for Wellell Inc in New Taipei City. 3 FDA inspections on record, 1 Form 483, last inspected May 05, 2017.
Company Profile
This profile covers Wellell Inc based in New Taipei City, Taiwan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 23, 2012. Last inspected May 5, 2017.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Complaints1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 5, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1013148 |
| November 7, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 906360 |
| February 23, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 773367 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Wellell Inc
FEI Number
3004411059
Address
No. 9 Minsheng St., Tucheng Dist., New Taipei City, Taiwan
Country
Taiwan
ID: 464e2887-72c4-473d-bb30-b384b75febaf