FDA Inspection
CareHealth America DBA Express Diagnostics InternationalCareHealth America DBA Express Diagnostics International – FDA Inspection, Jan 20, 2011
Record Details
This FDA Inspection record concerns CareHealth America DBA Express Diagnostics International, with an inspection on January 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 20, 2011
- Product Type
- Devices
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ID · ca2a8032-c0c7-4b2f-893b-4e881ad4830a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 706649
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of CareHealth America DBA Express Diagnostics International
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 25, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 13, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2008 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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