483
C.R. Bard Inc.C.R. Bard Inc. – FDA 483, Jun 5, 2026
Record Details
C.R. Bard Inc., a medical device contract manufacturer in Queensbury, NY, was cited for two significant issues during an FDA inspection. The firm failed to adequately document corrective action procedures, specifically regarding the review of effectiveness. Additionally, their risk management processes for Lutonix 035 Drug Coated Balloon PTA Catheters were found to be inadequately documented, leading to potential unidentified harms related to residuals.
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ID · 9436a2f3-9eef-4455-856a-315f24be7446
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