Oregon Fertility Institute, LLC FDA Inspection Record
Oregon Fertility Institute, LLC is an FDA-inspected facility (FEI 3008307753) located in Portland, OR, US. RegDataLab tracks 8 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Apr 10, 2025: No Action Indicated (NAI)
- Inspections on record
- 8 (5 VAI, 3 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 10, 2025 | No Action Indicated (NAI) | No citations listed |
| Aug 18, 2021 | Voluntary Action Indicated (VAI) | Donor screening standards (21 CFR 1271.50(b)(1)) |
| Oct 10, 2017 | No Action Indicated (NAI) | No citations listed |
| Apr 14, 2015 | No Action Indicated (NAI) | No citations listed |
| Jun 27, 2014 | Voluntary Action Indicated (VAI) | Testing, screening, donor eligibility procedures (21 CFR 1271.47(a)) |
| May 22, 2013 | Voluntary Action Indicated (VAI) | Testing, screening, donor eligibility procedures (21 CFR 1271.47(a)) |
| Jul 19, 2012 | Voluntary Action Indicated (VAI) | Design of procedures to ensure compliance (21 CFR 1271.47(a)) Ensurane of compliance (21 CFR 1271.150(c)(1)(iii)) Responsibility for review before distribution (21 CFR 1271.150(c)(2)) |
| Apr 27, 2011 | Voluntary Action Indicated (VAI) | Procedures for all other requirements (21 CFR 1271.47(a)) Name and personal info on accompanying records (21 CFR 1271.55(c)) Documentation--determination, by whom, date (21 CFR 1271.55(d)(1)(iii)) Ensurane of compliance (21 CFR 1271.150(c)(1)(iii)) and 1 more |
FDA record score
2 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
5 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Aug 18, 2021 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Jun 27, 2014 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | May 22, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jul 19, 2012 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Apr 27, 2011 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Oregon Fertility Institute, LLC
- Location
- Portland, OR (US)
- Source
- inspections