FDA 483 - Baystate Medical Center IRB - February 02, 2026

The Food and Drug Administration (FDA) conducted an inspection of Baystate Medical Center IRB, located in Springfield, Massachusetts, between January 28 and February 2, 2026. The inspection evaluated the Institutional Review Board"s compliance with federal standards for research oversight. The primary violation identified during this period concerned the inadequacy of meeting minutes, which lacked sufficient detail to demonstrate the board"s actions or official voting tallies. Specifically, investigators discovered that minutes for two separate meetings held in January and December 2024 contained identical verbatim descriptions for a specific study, failing to reflect the actual progress or deliberations of the board over that time. Additionally, records from an April 2025 meeting omitted the required counts of members voting for, against, or abstaining from decisions. These findings were issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While the report does not represent a final Agency determination, the organization is expected to respond. Baystate Medical Center IRB must address these administrative deficiencies by implementing corrective actions to ensure that all future meeting minutes accurately and uniquely document board discussions and voting results.