FDA 483 - Akom Pharmaceuticals, Inc. - April 09, 2018
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Akorn, Inc. received a Form 483 citing numerous deficiencies across its manufacturing operations. Key issues include poor aseptic processing techniques, inadequate environmental monitoring, failure to report critical changes and product issues, and insufficient investigations into discrepancies. The observations highlight systemic problems with quality control, data integrity, equipment design, and employee training, many of which are repeat observations from previous inspections.
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