Truemed Group LLC FDA Inspection Record
Truemed Group LLC is an FDA-inspected facility (FEI 3010393000) located in The Woodlands, TX, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 28, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (2 VAI, 1 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 28, 2025 | Voluntary Action Indicated (VAI) | Design history file (21 CFR 820.30(j)) Software validation for automated processes (21 CFR 820.70(i)) Distribution records (21 CFR 820.160(b)) Lack of Written MDR Procedures (21 CFR 803.17) |
| Jun 5, 2019 | Voluntary Action Indicated (VAI) | DHR content (21 CFR 820.184) Distribution records (21 CFR 820.160(b)) Lack of Written MDR Procedures (21 CFR 803.17) |
| Sep 11, 2015 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Truemed Group LLC
- Location
- The Woodlands, TX (US)
- Source
- inspections