Form FDA 483 · Issued 2026-02-02
Baystate Medical Center IRB — FDA Form 483 Analysis
FEI: 1283379 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Institutional Review Board) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Baystate Medical Center IRB (FEI 1283379) on 2026-02-02 following an inspection of its institutional review board operations in Massachusetts. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.180(b)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Record maintenance 1 year (except exempt OTC)
Inspector Observation Language: "All records of [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug product were not maintained at least one (1) year after the expiration date. Specifically, observed during inspection of Baystate Medical Center IRB on 2026-02-02."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · 21 CFR 211.186(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Signature and checking of records -- 2 persons
Inspector Observation Language: "The master production and control records for each batch size of drug product are not [prepared, dated, and signed by one person with a full handwritten signature] [independently checked, dated, and signed by a second person]. Specifically, observed during inspection of Baystate Medical Center IRB on 2026-02-02."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.