Meriter Health Enterprises — FDA Facility Profile
Meriter Health Enterprises is an FDA-inspected facility (FEI 3009166489) located in Madison, WI, US. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 7, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (1 VAI, 4 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Form 483 and inspection documents
- 1 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 7, 2025 | Voluntary Action Indicated (VAI) | Establishment of spec., standards, and test procedures (21 CFR 606.140(a)) Required records (21 CFR 606.160(b)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Feb 10, 2022 | No Action Indicated (NAI) | No citations listed |
| Oct 31, 2017 | No Action Indicated (NAI) | No citations listed |
| Dec 18, 2015 | No Action Indicated (NAI) | No citations listed |
| Nov 12, 2013 | No Action Indicated (NAI) | No citations listed |
Form 483s and inspection documents
- May 7, 2025: 483 on FDA.gov
Facility details
- Company
- Meriter Health Enterprises
- Location
- Madison, WI (US)
- Source
- inspections