FDA Inspection
HEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PVHEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PV – FDA Inspection, Dec 20, 2012
Record Details
This FDA Inspection record concerns HEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PV, with an inspection on December 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 20, 2012
- Product Type
- Devices
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ID · 11e4bd4c-c851-45d6-a802-cfe7cf2267b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811979
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 23, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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