FDA 483 - Lex, Inc. - February 28, 2023

Lex Inc. DBA Lex Pharmaceutical in Medley, FL, was cited for significant deficiencies in its manufacturing of OTC drugs and dietary supplements. The inspection revealed widespread issues including inadequate raw material testing, lack of process validation, and poor quality control practices. Many of these observations were repeats from prior FDA inspections, indicating a persistent failure to implement corrective actions.