483
BSN Medical IncFDA 483 - BSN Medical Inc - March 22, 2021
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Record Details
BSN Medical Inc. in Charlotte, NC, a specification developer and complaint unit, was inspected from March 15-22, 2021. The inspection revealed significant deficiencies in design control, process validation, and documentation practices. These issues indicate a lack of robust quality system implementation, particularly concerning design validation, process records, and timely approval of design inputs and outputs.
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