483
BALT USA, LLCFDA 483 - BALT USA, LLC - March 12, 2020
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Record Details
An FDA inspection of BARD USA, LLC, a medical device manufacturer in Irvine, CA, revealed a significant issue with their quality system. The firm failed to adequately establish procedures for controlling nonconforming products, specifically regarding the lack of root cause investigations for a substantial number of nonconformance reports. This indicates a moderate severity issue related to quality control and adherence to internal procedures.
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ID · e2d3fc62-759c-4012-82cd-6727249af8fe