FDA 483 - LISI MEDICAL Remmele, Inc - March 01, 2025

An FDA inspection conducted at LISI MEDICAL Remmele, Inc. from April 29, 2025, to May 1, 2025, identified significant issues related to quality system compliance. The inspection report, a Form FDA-483 issued under the Federal Food, Drug and Cosmetic Act, highlighted two main observations.

Firstly, the company's procedures for corrective and preventive actions (CAPA) were deemed inadequate. Specifically, SOP-852, governing CAPA implementation, failed to ensure that actions taken to address nonconformities were consistently verified or validated for effectiveness. Several nonconformance records were cited as lacking this crucial verification.

Secondly, the firm's training procedures were found to be deficient. SOP-622 and WI-622-007, which define employee training processes, did not adequately ensure that all essential job-specific training was identified or that employees performed tasks only after proper training. Examples included quality inspection personnel performing duties without necessary training on inspection plans and final inspection processes.

While the FDA-483 is not a final determination of compliance, it mandates that the firm is responsible for self-auditing and correcting all identified violations. LISI MEDICAL Remmele, Inc. has indicated a commitment to addressing both observations.