FDA 483 - C-Care, LLC - September 16, 2019

An FDA inspection of C-Care, LLC in Linthicum Heights, MD, a drug manufacturer, from September 9-16, 2019, revealed significant deficiencies in equipment cleaning and maintenance, facility sanitation and repair, and quality control oversight. Findings included visible debris on equipment, unsanitary conditions in production areas, structural issues in warehouses, and a lack of proper approval and record-keeping by the quality unit. These observations indicate a failure to adhere to good manufacturing practices.