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

An FDA inspection of Compass Health Brands Corp., located in Brook Park, OH, was conducted from November 3-17, 2021. The firm operates primarily as a warehouse, re-labeler, re-packer, and performs some manufacturing for a variety of Class I and Class II non-sterile medical devices, including CPAP products and TENS units. The inspection was carried out under compliance program 7382.845 for Medical Device Manufacturers, focusing on CAPA, complaint investigations, and production and process controls, including labeling. At the conclusion, an FDA-483 was issued detailing seven observations related to regulatory compliance under 21 CFR Part 820. Key issues included the absence of process validation studies for sealing and packaging equipment (21 CFR 820.75(a)), uncalibrated testing equipment (21 CFR 820.72(a)), and a lack of Unique Device Identifier (UDI) labeling on manufactured products (21 CFR 820.120(b)). Further findings involved inadequate label accountability, no validation studies to ensure label legibility and adherence (21 CFR 820.120(a)), a lack of shipping validation studies to protect devices during distribution (21 CFR 820.130), and inadequate incoming product inspection procedures, specifically regarding sampling sizes (21 CFR 820.80(b)). Michael A. Trodden, the DC Manager, acknowledged all observations, annotating them as "Promised to Correct." Management committed to immediate efforts to address the deficiencies, including beginning equipment qualification and validation, ensuring calibration, investigating labeling discrepancies, and formalizing shipping validation. A written response was expected within 15 business days.