New York Blood Center Enterprises FDA Inspection Record
New York Blood Center Enterprises is an FDA-inspected facility (FEI 3003490413) located in Melville, NY, US. RegDataLab tracks 7 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Dec 5, 2025: No Action Indicated (NAI)
- Inspections on record
- 7 (5 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 |
|---|---|---|
| Dec 5, 2025 | No Action Indicated (NAI) | Person performing, test results, interpretation (21 CFR 606.160(a)(1)) Following manufacturer's instructions (21 CFR 606.65(e)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Nov 9, 2020 | No Action Indicated (NAI) | Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Jan 16, 2018 | Voluntary Action Indicated (VAI) | Required records (21 CFR 606.160(b)) Provide proper equipment to meet requirements (21 CFR 606.60(a)) |
| Dec 18, 2015 | Voluntary Action Indicated (VAI) | Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Accurate measurement of quantity of blood (21 CFR 606.100(b)(5)) |
| Dec 23, 2013 | Voluntary Action Indicated (VAI) | Legibility and indelibility (21 CFR 606.160(a)(1)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Accurate measurement of quantity of blood (21 CFR 606.100(b)(5)) Biological product deviation report (21 CFR 606.171) |
| Mar 12, 2012 | Voluntary Action Indicated (VAI) | Procedures for all other requirements (21 CFR 1271.47(a)) Accurate, indelible, legible (21 CFR 1271.55(d)(2)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Mar 31, 2010 | Voluntary Action Indicated (VAI) | Concurrent documentation (21 CFR 606.160(a)(1)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
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 | Jan 16, 2018 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Dec 18, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Dec 23, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Mar 12, 2012 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Mar 31, 2010 | 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
- New York Blood Center Enterprises
- Location
- Melville, NY (US)
- Source
- inspections