FDA 483 - Compass Health Brands Corp. - November 17, 2021

Compass Health Brands Corp. in Brook Park, OH, was cited for multiple deficiencies related to equipment qualification, calibration, labeling controls, and packaging studies during an FDA inspection. The observations indicate a lack of validated processes for sealing and packaging equipment, uncalibrated testing equipment, and inadequate procedures for UDI labeling and label accountability. Additionally, the firm failed to conduct studies to ensure label legibility/adhesion and device protection during distribution, and lacked established procedures for incoming product acceptance.