Company
TaiwanHeadstar Medical Products Co., Ltd., New Taipei City, Taiwan – FDA Inspections
Inspection records and compliance data for Headstar Medical Products Co., Ltd. in New Taipei City. 3 FDA inspections on record, 2 Form 483s, last inspected May 22, 2025.
Company Profile
This profile covers Headstar Medical Products Co., Ltd. based in New Taipei City, Taiwan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 5, 2009. Last inspected May 22, 2025.
Most cited issue areas
- Acceptance records1 inspection
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Contamination control, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2025 | Not classified | Medical Devices & Rad Health | 1273924 |
| December 15, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 994816 |
| November 5, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 636134 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Headstar Medical Products Co., Ltd.
FEI Number
3003418980
Address
7F, No. 14, WU-GONG 5th Rd., WU-GU Dist., New Taipei City, Taiwan
Country
Taiwan
ID: c9e05d9e-3480-46b4-8a4b-40eb6b527e2b