Baystate Medical Center IRB
Form 483 issued February 2, 2026 · Springfield, Massachusetts
- Inspection
- Jan 28 – Feb 2, 2026
- Investigators
- Agata E. Libera· Jose A. Torres
- Observations
- 1
- Pages
- 2
- FEI number
- 1283379
In short: On February 2, 2026, FDA issued a Form 483 with 1 observation to Baystate Medical Center IRB in Springfield, Massachusetts (FEI 1283379) after an inspection that ran Jan 28 – Feb 2, 2026. The investigators were Agata E. Libera and Jose A. Torres. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 56.115 (iRB records).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 56.115(a)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Minutes of IRB meetings have not been prepared in sufficient detail to show actions taken by…
This inspection in context
Agata E. Libera
1 document · 2026
Cites 56.115(a)(2) (irb records) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBaystate Medical Center IRB history
The site's inspection history, in date order.
Similar 483sOther sites cited under 56.115(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baystate Medical Center IRB?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 56.115 (iRB records). The opening words of each observation are shown on this page.
Who inspected Baystate Medical Center IRB?
Agata E. Libera and Jose A. Torres are named on this Form 483, for the inspection of Jan 28 – Feb 2, 2026. Each investigator has a profile showing what they cite most.
When was Baystate Medical Center IRB inspected by FDA?
The inspection ran Jan 28 – Feb 2, 2026, and the Form 483 is dated February 2, 2026.
How do I get the full Form 483 for Baystate Medical Center IRB?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.