FDA 483 - Xyresic Llc - December 16, 2024

Xyresic Llc, a contract manufacturer in Jackson, MI, was cited for two significant issues during an FDA inspection. The firm failed to adequately establish procedures for controlling suppliers, including initial evaluation, classification, monitoring, and removal of approved suppliers. Additionally, procedures for controlling nonconforming products were deficient, specifically lacking documentation regarding the need for investigations on Non-Conformance Report forms.