483
Xyresic LlcXyresic Llc – FDA 483, Dec 16, 2024
Record Details
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.
View Company Profile
ID · 3601d34b-c192-435e-aed4-54de1848590f
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.