FDA 483 - Slater Endoscopy, LLC - September 26, 2025

An FDA inspection of Slater Endoscopy, LLC, conducted from September 22-26, 2025, identified multiple deficiencies in the company's quality system regarding the manufacturing of their Ensizor Endoscopic Scissors. The observations, issued under the Federal Food, Drug and Cosmetic Act, highlight areas requiring immediate corrective action.

Key issues included inadequate procedures for Medical Device Reporting (MDR), where the firm failed to evaluate reported events and lacked an electronic system for timely submission to the FDA. Complaint handling processes were also deficient, with several device malfunction complaints not properly investigated, escalated to corrective actions, or assessed for MDR reportability. Furthermore, the company failed to adequately control and calibrate manufacturing equipment, with multiple microscopes and measuring devices lacking proper documentation. Supplier management records were insufficient, specifically for a critical supplier providing services since 2019. Finally, device history records for released product lots lacked required signatures, indicating a lapse in acceptance activities.

Slater Endoscopy, LLC is required to address these inspectional observations by either presenting objections to the FDA or implementing and documenting comprehensive corrective actions. The company must ensure full compliance with established quality system regulations through internal self-audits and rectifications.