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Talk to a SpecialistTalk to a SpecialistNoah Medical Corporation, a manufacturer of bronchoscopes and accessories (Galaxy System), was found to have produced adulterated devices that failed to comply with current good manufacturing practice requirements under FDA's Quality System Regulation (21 CFR Part 820). During an inspection conducted from October 28 through November 26, 2024, investigators identified that the company failed to establish and maintain adequate procedures for corrective and preventive action (CAPA), including inadequate investigations and documentation of identified issues. The violations were documented on FDA Form 483 and the company provided responses in December 2024 and January 2025, which the FDA found to be insufficient to address the manufacturing and quality control deficiencies.