Hansen Ophthalmic Development Laboratory Inc. FDA Inspection Record
Hansen Ophthalmic Development Laboratory Inc. is an FDA-inspected facility (FEI 1935505) located in Bellingham, WA, US. RegDataLab tracks 4 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 11, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (2 VAI, 2 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 11, 2025 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Label to bear a unique device identifier (21 CFR 801.20(a)) Quality audits - Lack of or inadequate procedures (21 CFR 820.22) Design control - no procedures (21 CFR 820.30(a)) and 6 more |
| Oct 12, 2016 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) DHR content (21 CFR 820.184) |
| Oct 30, 2013 | No Action Indicated (NAI) | No citations listed |
| Feb 22, 2012 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Hansen Ophthalmic Development Laboratory Inc.
- Location
- Bellingham, WA (US)
- Source
- inspections