483
Eurofins Advantar Laboratories, IncEurofins Advantar Laboratories, Inc – FDA 483, Jun 30, 2026
Record Details
Eurofins Advantar Laboratories, LLC in San Diego, CA, an API manufacturer and contract testing lab, was cited for failing to follow its written procedures for Annual Product Quality Reviews (APQR). The firm did not establish APQR schedules or finalize reviews for API drug substances in a timely manner as required by its own standard operating procedure. This indicates a lapse in adherence to established quality control processes.
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ID · f98de7ac-2761-4994-b643-2d70f0c2fe26
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