Company
United StatesCareHealth America DBA Express Diagnostics International, Blue Earth, MN – FDA Inspections
Inspection records and compliance data for CareHealth America DBA Express Diagnostics International in Blue Earth, Minnesota. 6 FDA inspections on record (2 OAI), last inspected January 25, 2024.
Company Profile
This profile covers CareHealth America DBA Express Diagnostics International based in Blue Earth, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 2
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 29, 2008. Last inspected January 25, 2024.
Most cited issue areas
- Process control procedures, Lack of or inadequate procedures2 inspections
- Examination for accuracy1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 25, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1229070 |
| September 25, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 949582 |
| June 24, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 883813 |
| July 13, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 734603 |
| January 20, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 706649 |
| October 29, 2008 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 543591 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
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Company Information
Name
CareHealth America DBA Express Diagnostics International
FEI Number
3014946040
Address
1550 Industrial Dr, Blue Earth, Minnesota 56013, United States
Country
United States
ID: cd0a11fd-f349-44f8-af80-9d02352a9e62