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Owens & Minor, Inc. dba American Contract Systems, Inc. manufactured sterile convenience kits, including C-Section Packs, that were found to be adulterated due to failure to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. A critical violation involved the company's failure to establish and maintain procedures for accepting incoming products, including inadequate inspection, testing, and verification of conformity to specified requirements, with documented instances occurring at least four times between January and July 2024. The FDA inspection was conducted August 5-14, 2024 at the company's Tiffin, Ohio facility, and the company submitted a response to the investigator's observations in September 2024.