FDA 483 - Coeur, Inc. - March 29, 2018

Coeur, Inc., a Class II Medical Devices Manufacturer in Washington, NC, received a Form FDA 483 with four observations following an inspection. The firm demonstrated significant deficiencies in its quality system, including inadequate procedures for corrective and preventive actions, undocumented process validation, poor document control, and insufficient equipment maintenance. These issues collectively indicate a need for substantial improvements in their manufacturing and quality management practices.