FDA Inspection
Headstar Medical Products Co., Ltd.Headstar Medical Products Co., Ltd. – FDA Inspection, Nov 5, 2009
Record Details
This FDA Inspection record concerns Headstar Medical Products Co., Ltd., with an inspection on November 5, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 5, 2009
- Product Type
- Devices
View Company Profile
ID · 120bed40-271a-4d66-ac88-5dc88c778a9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 636134
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.80(b)Incoming inspection, testing, verification
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Headstar Medical Products Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2025 | Not classified | Office of Inspections and Investigations | |
| December 15, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Headstar Medical Products Co., Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.