Company
IndiaHEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PV, Bangalore, India – FDA Inspections
Inspection records and compliance data for HEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PV in Bangalore. 3 FDA inspections on record (1 OAI), last inspected April 29, 2016.
Company Profile
This profile covers HEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PV based in Bangalore, India.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 23, 2010. Last inspected April 29, 2016.
Most cited issue areas
- Design control - no procedures1 inspection
- DMR QA procedures and specifications1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 29, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 986076 |
| December 20, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 811979 |
| April 23, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 662414 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
HEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PV
FEI Number
3004944585
Address
472 D 13th Cross, 4TH PHASE, PEENYA INDUSTRIAL AREA, Bangalore, India
Country
India
ID: e4d651db-4ead-4b6c-b1a1-16e260b305ad