FDA 483 - C-Care, LLC - September 16, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 6f6a0e44-ef35-4017-aa64-58078bd9cf14