483
RC Outsourcing, LLCRC Outsourcing, LLC – FDA 483, Sep 23, 2022
Record Details
RC Outsourcing LLC, an outsourcing facility in Lowellville, OH, was inspected regarding its sterile drug repackaging operations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, quality control unit responsibilities, and equipment calibration. Additionally, the firm failed to submit adverse event reports to the FDA in a timely manner.
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ID · e002c475-7b79-42ee-a975-e5d639a81873
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