Barnes-Jewish Hospital Blood Bank FDA Inspection Record
Barnes-Jewish Hospital Blood Bank is an FDA-inspected facility (FEI 1974272) located in Saint Louis, MO, US. RegDataLab tracks 9 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- May 16, 2024: No Action Indicated (NAI)
- Inspections on record
- 9 (5 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 16, 2024 | No Action Indicated (NAI) | No citations listed |
| Mar 5, 2020 | No Action Indicated (NAI) | No citations listed |
| Apr 12, 2018 | No Action Indicated (NAI) | No citations listed |
| Apr 26, 2016 | Voluntary Action Indicated (VAI) | Biological product deviation report (21 CFR 606.171) Thorough investigations (21 CFR 606.100(c)) |
| Feb 6, 2014 | Voluntary Action Indicated (VAI) | Corrective action (21 CFR 640.25(b)(4)) Qualifications of responsible personnel (21 CFR 606.20(b)) Procedures to relate blood from donor to final disposition (21 CFR 606.100(b)(13)) Biological product deviation report (21 CFR 606.171) |
| Jun 6, 2012 | Voluntary Action Indicated (VAI) | Concurrent documentation (21 CFR 606.160(a)(1)) Required records (21 CFR 606.160(b)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Personnel capabilities (21 CFR 600.10(b)) and 1 more |
| Sep 14, 2011 | Voluntary Action Indicated (VAI) | Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Personnel capabilities (21 CFR 600.10(b)) Thorough investigations (21 CFR 606.100(c)) |
| Mar 15, 2011 | Voluntary Action Indicated (VAI) | Concurrent documentation (21 CFR 606.160(a)(1)) Distribution records - content (21 CFR 606.165(b)) Written record not kept of program and validation data (21 CFR 211.68(b)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) and 4 more |
| Jan 22, 2009 | No Action Indicated (NAI) | No citations listed |
FDA record score
0 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 | Apr 26, 2016 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Feb 6, 2014 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jun 6, 2012 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Sep 14, 2011 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Mar 15, 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 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 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 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Barnes-Jewish Hospital Blood Bank
- Location
- Saint Louis, MO (US)
- Source
- inspections