FDA Inspection
Heartsine Technologies IncHeartsine Technologies Inc – FDA Inspection, Aug 22, 2013
Record Details
This FDA Inspection record concerns Heartsine Technologies Inc, with an inspection on August 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Heartsine Technologies Inc
- Inspection Date
- August 22, 2013
- Product Type
- Devices
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ID · e05d9d50-5d24-4eac-8a93-333c0b7104c2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 847671
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 821.25(c)Not established, maintained
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Other FDA inspections of Heartsine Technologies Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 16, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 16, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 4, 2009 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Heartsine Technologies Inc
- FDA Inspection 1068673 - 2018-05-03
- FDA Inspection 897171 - 2014-09-16
- FDA Inspection 652945 - 2010-03-16
- FDA Inspection 601913 - 2009-08-04
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