Company
TaiwanHeartway Medical Products Co., Ltd., Taichung, Taiwan – FDA Inspections
Inspection records and compliance data for Heartway Medical Products Co., Ltd. in Taichung. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected June 22, 2017.
Company Profile
This profile covers Heartway Medical Products Co., Ltd. based in Taichung, Taiwan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected October 27, 2011. Last inspected June 22, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - output does not meet input requirement1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 22, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1016647 |
| March 11, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 925359 |
| October 27, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 753535 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Heartway Medical Products Co., Ltd.
FEI Number
3002847480
Address
No. 6 Road, 25 Taichung Industrial Park, Taichung, Taiwan
Country
Taiwan
ID: 7e99e79d-f1e3-4b9a-be20-20c454ff768f