Laboratorios B. Braun S.A – FDA Warning Letter, Feb 24, 2011

An FDA inspection of Laboratorios B. Braun S.A. (Sau Goncalo, Brazil) from February 21-24, 2011, found its intravascular extension sets and liquid medication dispensers adulterated and misbranded. Adulteration stemmed from non-compliance with Quality System (QS) regulation (21 CFR Part 820) CGMP requirements, and misbranding from failures related to Medical Device Reporting (MDR) regulations (21 CFR Part 803). Key violations included: failure to establish procedures for controlling nonconforming product (21 CFR 820.90(a)); inadequate procedures for receiving, reviewing, and evaluating complaints, particularly for MDR determination (21 CFR 820.198); failure to maintain complete Device History Records (DHRs), lacking documentation of final quantities released (21 CFR 820.184); and failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17). FDA emphasized the firm's manufacturer responsibility under 21 CFR Part 803, despite a quality agreement with B. Braun Medical US (BBMUS). The firm's response detailed corrective actions, including procedure revisions and an MDR exemption request (granted for single MDR submission by BBMUS). However, FDA found the revised MDR procedure (P-0006, Version 17) inadequate, failing to address timely MDR submission or documentation/record-keeping per 21 CFR 803.17 and 803.18. FDA recommended separating MDR reporting into a distinct document. The firm must notify FDA within fifteen working days of specific corrective steps, with documentation and a timetable. A follow-up inspection is required, and federal agencies are advised of this Warning Letter for contract considerations.