483
Lentigen Technology, Inc.Lentigen Technology, Inc. – FDA 483, Jun 24, 2026
Record Details
Lentigen Technology Inc. in Gaithersburg, MD, a drug substance intermediate manufacturer, was cited for failing to fully evaluate discrepancies involving bioburden excursions. The firm's risk assessment was found deficient in evaluating microbial contamination events that occurred during the manufacture of lentiviral products for commercial use, specifically omitting an Out of Specification (OOS) event related to a bioburden excursion.
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ID · 3db94bb2-aeda-4c5d-8bd5-53d83690517b
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