483
Concert Medical, LLCConcert Medical, LLC – FDA 483, Mar 5, 2020
Record Details
An FDA inspection of Concert Medical, LLC, a manufacturer of coronary guidewires in Norwell, MA, identified a significant quality system deficiency. The firm failed to adequately establish and follow procedures for controlling environmental conditions. Specifically, their SOP for timely completion of cleaning and maintenance logs in a controlled environment room was not followed during manufacturing.
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ID · e3696550-433f-4aa9-bdfe-642382aa5354
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