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Talk to a SpecialistTalk to a SpecialistRechon Life Science AB, a Swedish drug manufacturer, was found to have manufactured adulterated sterile pharmaceutical products due to significant Current Good Manufacturing Practice (CGMP) violations. The company failed to establish and follow adequate written procedures to prevent microbiological contamination during aseptic processing, specifically allowing operators to touch critical equipment components with gloved hands during the setup and assembly of sterile filling lines—a practice explicitly permitted in their standard operating procedures. The FDA conducted an inspection of the facility from August 26 to September 6, 2024, and determined that the firm's methods, facilities, and controls for manufacturing and processing did not conform to CGMP regulations under 21 CFR parts 210 and 211.