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Adept Medical Ltd. manufactured Tympanostomy Tubes (NeoZoline Ventilation Tubes) in violation of current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. An FDA inspection conducted in May 2024 identified failures to establish and maintain adequate procedures for acceptance activities, including incoming inspections and tests, with particular concerns regarding the firm's handling of Biological Indicator certificates of conformance—a deficiency that could compromise the sterilization process and affect product safety and effectiveness. The company's June 2024 response to the FDA's inspectional observations was deemed inadequate to address the identified violations.