Company
TaiwanWell-Life Healthcare Limited, New Taipei City, Taiwan – FDA Inspections
Inspection records and compliance data for Well-Life Healthcare Limited in New Taipei City. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected June 01, 2017.
Company Profile
This profile covers Well-Life Healthcare Limited based in New Taipei City, Taiwan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 2, 2010. Last inspected June 1, 2017.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Document review, approval by designated individual1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 1, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1015062 |
| August 29, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 852984 |
| December 2, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 704481 |
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
Well-Life Healthcare Limited
FEI Number
3006850006
Address
Jhonghe District, No. 168, 6 F; Lide St.; Zhonghe Dist., New Taipei City, Taiwan
Country
Taiwan
ID: b3c1aa4d-ca60-42fe-b4c5-c6b5a0bf20b7