Tecomet, Inc. — FDA Facility Profile
Tecomet, Inc. is an FDA-inspected facility (FEI 3007137928) located in Boulder, CO, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 18, 2024: 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 18, 2024 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) |
| Nov 15, 2019 | No Action Indicated (NAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Quality audits - Lack of or inadequate procedures (21 CFR 820.22) Software validation for automated processes (21 CFR 820.70(i)) Lack of or inadequate procedures - Acceptance activities (21 CFR 820.80(a)) and 4 more |
| Oct 9, 2015 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) Lack of or inadequate process validation (21 CFR 820.75(a)) |
Facility details
- Company
- Tecomet, Inc.
- Location
- Boulder, CO (US)
- Source
- inspections