FDA 483 - Unomedical s.r.o. - October 26, 2018

An FDA inspection of Unomedical s.r.o., a medical device manufacturer located in Michalovce, Slovakia, was conducted from October 24 to October 26, 2018. The inspection, carried out by Investigator John A. Sciacchitano, resulted in the issuance of an FDA Form 483, detailing observations of non-compliance with regulatory quality system requirements. The primary observation noted during the inspection was that the company's procedures for quality audits were not adequately established. Specifically, the audit process lacked clear guidelines for auditing records, such as the sample method, sample size, and time frame involved. This indicates a deficiency in the firm's internal control mechanisms designed to ensure product quality and regulatory adherence. While the FDA Form 483 does not constitute a final determination of compliance, it serves as notification of objectionable conditions found during the inspection. Unomedical s.r.o. is responsible for conducting internal self-audits to identify and correct all violations of quality system requirements. The firm is expected to address these observations by implementing appropriate corrective actions to bring its quality audit procedures into full compliance with applicable regulations, thereby ensuring the safety and effectiveness of its manufactured medical devices.