FDA 483 - RCS Management Corporation dba Lincare AAC - June 29, 2023

An FDA inspection of RCS Management Corporation dba Lincare AAC in Surprise, AZ, a medical device manufacturer, revealed two significant observations. The firm failed to establish procedures for corrective and preventive actions and did not implement unique device identifiers (UDI) on its medical device labels as required by regulations. These issues indicate non-compliance with quality system and labeling requirements.