Hansen Ophthalmic Development Laboratory Inc. FDA Record
Hansen Ophthalmic Development Laboratory Inc. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Hansen Ophthalmic Development Laboratory Inc." is on file.
- Latest inspection
- Apr 11, 2025 · VAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 4 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 11, 2025 | Bellingham, WA | Devices | Voluntary Action Indicated (VAI) | 1935505 |
| Oct 12, 2016 | Bellingham, WA | Devices | Voluntary Action Indicated (VAI) | 1935505 |
| Oct 30, 2013 | Bellingham, WA | Devices | No Action Indicated (NAI) | 1935505 |
| Feb 22, 2012 | Bellingham, WA | Devices | No Action Indicated (NAI) | 1935505 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1935505 | Bellingham, WA | 4 | Apr 11, 2025 |
Hansen Ophthalmic Development Laboratory Inc. and the FDA: common questions
Has Hansen Ophthalmic Development Laboratory Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Hansen Ophthalmic Development Laboratory Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Hansen Ophthalmic Development Laboratory Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Hansen Ophthalmic Development Laboratory Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Hansen Ophthalmic Development Laboratory Inc.?
The most recent FDA inspection on file ended Apr 11, 2025 at Bellingham, WA and was classified VAI. FDA has 4 inspections of Hansen Ophthalmic Development Laboratory Inc. on file.
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