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Zyno Medical LLC, a manufacturer of infusion pumps and administration sets including the Z-800 series, was found to be producing adulterated devices that failed to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. The inspection conducted January 29 – February 15, 2022 identified violations including failure to adequately establish and maintain corrective and preventive action (CAPA) procedures as required by 21 CFR 820.100(a), with deficiencies noted in the firm's CAPA procedure (006-SOP Rev K) regarding statistical methodology requirements. The company submitted multiple responses to FDA's inspection observations between March and June 2022 but did not achieve full compliance remediation.