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Talk to a SpecialistTalk to a SpecialistLiebel-Flarsheim Company LLC's Raleigh, North Carolina facility, which manufactures sterile injectable drug products, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. During a March-April 2025 FDA inspection, investigators identified significant violations including failure to thoroughly investigate unexplained batch discrepancies and out-of-specification results, specifically multiple microbial excursions in in-process samples and out-of-specification endotoxin results in finished sterile drugs. The company also failed to implement adequate corrective and preventive actions (CAPAs) in response to these quality failures. This amended warning letter (issued October 17, 2025) replaced an initial version from October 15, 2025.