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Talk to a SpecialistTalk to a SpecialistMiach Orthopaedics was cited for manufacturing the Bridge-Enhanced ACL Restoration (BEAR) Implant in violation of current good manufacturing practice requirements under the Quality System Regulation (21 CFR Part 820). The inspection conducted from March 31 through April 23, 2025 identified failures to establish and maintain procedures for monitoring and control of process parameters in validated processes, specifically regarding dose audits to ensure the sterility assurance level of the firm's E-Beam sterilization process continued to be met. The devices were determined to be adulterated due to inadequate manufacturing controls, facilities, and methods used in their production.