483
EUSA Global, LLCFDA 483 - EUSA Global, LLC - October 15, 2021
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An FDA inspection of EUSA Global, LLC dba Ecleris USA in Medley, FL, a contract manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for handling complaints, controlling manufacturing processes, and accepting incoming products. These issues indicate a lack of robust quality management practices.
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ID · 3c4564b8-2a27-4cfd-8749-82adca29a3ab