FDA Inspection
HEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PVHEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PV – FDA Inspection, Apr 23, 2010
Record Details
This FDA Inspection record concerns HEALTHIUM MEDTECH PRIVATE LIMITED (FORMERLY SUTURES INDIA PV, with an inspection on April 23, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 23, 2010
- Product Type
- Devices
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ID · d2adde70-361e-4dbf-8a89-675304d6e401
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 662414
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.181(c)DMR QA procedures and specifications
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| December 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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