FDA Inspection
CareHealth America DBA Express Diagnostics InternationalCareHealth America DBA Express Diagnostics International – FDA Inspection, Jun 24, 2014
Record Details
This FDA Inspection record concerns CareHealth America DBA Express Diagnostics International, with an inspection on June 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 24, 2014
- Product Type
- Devices
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ID · f96cbaac-d4f8-4b29-885a-ee3193ada458
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 883813
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 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 |
| July 13, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 20, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2008 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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