Company
TaiwanAPEX HEALTH CARE MFG., INC., Min Hsiung Shiang, Taiwan – FDA Inspections
Inspection records and compliance data for APEX HEALTH CARE MFG., INC. in Min Hsiung Shiang, -. 4 FDA inspections on record, last inspected August 15, 2024.
Company Profile
This profile covers APEX HEALTH CARE MFG., INC. based in Min Hsiung Shiang, Taiwan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected December 2, 2010. Last inspected August 15, 2024.
Most cited issue areas
- Documentation1 inspection
- Incorrect translation to production specifications1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 15, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1249556 |
| August 16, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1066943 |
| August 23, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 847004 |
| December 2, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 705655 |
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
APEX HEALTH CARE MFG., INC.
FEI Number
3010605276
Address
Tou Chiao Industrial Park, No. 6 Industrial 2nd Road, Min Hsiung Shiang, - -, Taiwan
Country
Taiwan
ID: 0894ab02-fca6-4a3a-af30-a5891b469626