Baystate Medical Center IRB FDA Inspection Record
Baystate Medical Center IRB is an FDA-inspected facility (FEI 1283379) located in Springfield, MA, US. RegDataLab tracks 4 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Feb 2, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (2 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
- Form 483 and inspection documents
- 1 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 2, 2026 | Voluntary Action Indicated (VAI) | Minutes of IRB meetings (21 CFR 56.115(a)(2)) |
| Mar 1, 2019 | No Action Indicated (NAI) | No citations listed |
| Jul 10, 2014 | No Action Indicated (NAI) | No citations listed |
| May 12, 2009 | Voluntary Action Indicated (VAI) | Initial and continuing reviews (21 CFR 56.108(a)(1)) Members present for review (21 CFR 56.108(c)) Reporting of suspension/termination (21 CFR 56.108(b)(3)) |
Form 483s and inspection documents
FDA record score
6 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.
2 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Feb 2, 2026 | 6 x 1 | 6 |
| Inspection classified VAI | May 12, 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 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
- Baystate Medical Center IRB
- Location
- Springfield, MA (US)
- Source
- inspections