Lentigen Technology, Inc.June 24, 2026

FDA 483 - Lentigen Technology, Inc. - June 24, 2026

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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.

Company: Lentigen Technology, Inc.
Inspection Date: June 24, 2026
Product Type: Drugs
Office: Office of Regulatory Affairs
Person: Priscilla M. Pastrana (investigator)

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ID · 3db94bb2-aeda-4c5d-8bd5-53d83690517b