FDA 483 - Safecor Health, LLC - February 02, 2018

An FDA inspection of SAFCOR Health LLC, a repackager of single unit dose oral solids and liquids in Columbus, OH, revealed significant deficiencies. The firm failed to complete investigations within required timeframes, employees did not wear appropriate protective apparel during repackaging, and the facility lacked suitable construction features to ensure proper gowning and prevent contamination. These issues indicate a lack of adherence to quality control procedures and good manufacturing practices.