Kofinas Fertility Group FDA Inspection Record
Kofinas Fertility Group is an FDA-inspected facility (FEI 3004753467) located in New York, NY, US. RegDataLab tracks 8 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Apr 9, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 8 (4 VAI, 4 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
- Form 483 and inspection documents
- 1 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 9, 2025 | Voluntary Action Indicated (VAI) | Determination based on screening and testing (21 CFR 1271.50(a)) Responsible person to determine, document (21 CFR 1271.50(a)) Accurate, indelible, legible (21 CFR 1271.55(d)(2)) Eligibility not required--warning labels (21 CFR 1271.90(c)) |
| Jul 25, 2023 | Voluntary Action Indicated (VAI) | Determination based on screening and testing (21 CFR 1271.50(a)) Responsible person to determine, document (21 CFR 1271.50(a)) Accurate, indelible, legible (21 CFR 1271.55(d)(2)) |
| Feb 13, 2020 | No Action Indicated (NAI) | No citations listed |
| Jun 25, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Mar 11, 2016 | No Action Indicated (NAI) | No citations listed |
| Dec 4, 2013 | No Action Indicated (NAI) | No citations listed |
| Sep 13, 2012 | No Action Indicated (NAI) | No citations listed |
| Aug 19, 2009 | Voluntary Action Indicated (VAI) | Procedures for all other requirements (21 CFR 1271.47(a)) Responsible person to determine, document (21 CFR 1271.50(a)) Accurate, indelible, legible (21 CFR 1271.55(d)(2)) Abbreviated procedure (21 CFR 1271.75(e)) |
Form 483s and inspection documents
FDA record score
11 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.
4 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Apr 9, 2025 | 6 x 1 | 6 |
| Inspection classified VAI | Jul 25, 2023 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Jun 25, 2018 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Aug 19, 2009 | 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
- Kofinas Fertility Group
- Location
- New York, NY (US)
- Source
- inspections