FDA 483 - Sheffield Pharmaceuticals, LLC - March 15, 2019

An FDA inspection of Sheffield Pharmaceuticals, LLC in New London, CT, revealed multiple significant deficiencies across various quality system procedures. The firm was cited for inadequate procedures related to design change, corrective and preventive actions, nonconforming product disposition, equipment calibration and maintenance, complaint handling, and document control. These observations indicate a systemic lack of robust quality management practices.