483
Links Medical Products IncLinks Medical Products Inc – FDA 483, Oct 18, 2023
Record Details
An FDA inspection of Links Medical Products Inc, a manufacturer in Laguna Hills, CA, identified significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and follow its CAPA process, resulting in numerous overdue and unverified CAPAs. This indicates a breakdown in the quality system for addressing and preventing issues.
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ID · 0e85ee88-1e7b-45e5-af29-3321dba6bad8
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