FDA 483 - Liebel-Flarsheim Company LLC - April 08, 2025

Liebel-Flarsheim Company LLC, a drug product manufacturer in Raleigh, NC, was cited for significant deficiencies during an FDA inspection. Observations included inadequate investigations into out-of-specification results, poor maintenance of aseptic processing areas and facility infrastructure, and the use of non-validated spreadsheets for critical laboratory testing. Additionally, employee training and adherence to aseptic sampling procedures were found to be insufficient.