CareHealth America DBA Express Diagnostics International — FDA Facility Profile
CareHealth America DBA Express Diagnostics International is an FDA-inspected facility (FEI 3014946040) located in Blue Earth, MN, US. RegDataLab tracks 6 FDA inspections and 3 compliance actions at this facility.
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What FDA found at this site
- Latest inspection
- Jan 25, 2024: No Action Indicated (NAI)
- Inspections on record
- 6 (2 OAI, 2 VAI, 2 NAI)
- Last OAI inspection
- Jun 24, 2014
- Warning letters
- 3 listed by FDA for this FEI, latest Sep 17, 2014
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jan 25, 2024 | No Action Indicated (NAI) | No citations listed |
| Sep 25, 2015 | No Action Indicated (NAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Procedures not adequately established or maintained (21 CFR 820.40) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) |
| Jun 24, 2014 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Lack of or inadequate In-process acceptance procedures (21 CFR 820.80(c)) Lack of or inadequate procedures (21 CFR 820.100(a)) Procedures for product review,disposition lack of/inadequate (21 CFR 820.90(b)(1)) and 2 more |
| Jul 13, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Jan 20, 2011 | Official Action Indicated (OAI) | Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) Examination for accuracy (21 CFR 820.120(b)) Process control procedures, Lack of or inadequate procedures (21 CFR 820.70(a)) |
| Oct 29, 2008 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- CareHealth America
- Location
- Blue Earth, MN (US)
- Source
- inspections