FDA WARNING_LETTER - Beckman Coulter, Inc. - May 12, 2011

An FDA inspection of Beckman Coulter, Inc. in Brea, California, from March 1 to May 12, 2011, revealed significant violations concerning the manufacture of Class II diagnostic chemistry analyzers and related products. The firm's devices were found to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide information required by 21 U.S.C. § 360i and 21 CFR Parts 803 (Medical Device Reporting) and 806 (Reports of Corrections and Removals). Key QS violations included inadequate procedures for design changes, design validation, design plan review, personnel training, and corrective and preventive actions (CAPA), including insufficient documentation of CAPA activities. Medical Device Reporting deficiencies involved failures to report malfunctions within 30 days, submit all known information, implement written MDR procedures, and include required details like remedial actions and report sources. Additionally, the firm failed to report a correction and removal of its Synchron Systems LX-20/Unicel DxC ISE Reference Reagent to the FDA. The firm's response to the FDA 483 was deemed inadequate. Beckman Coulter must take prompt action to correct these violations and provide a written response within fifteen business days, detailing corrective actions, prevention plans, and a timeline. Failure to comply could result in severe regulatory actions, including seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.