483
Radiometer Basel AGFDA 483 - Radiometer Basel AG - October 20, 2016
Record Details
Radiometer Basel AG, a medical device manufacturer in Basel, Switzerland, was cited for two significant observations during an FDA inspection. The firm failed to adequately verify design output against design input requirements for its TCM5 monitor and lacked established procedures for controlling nonconforming products. These issues highlight deficiencies in the company's quality system.
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ID · 37407e05-4f56-4273-9ea7-1a6371f2254a