FDA 483 - Splintek, Inc - October 30, 2025

During an inspection conducted from October 29-30, 2025, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Splintek, Inc., a medical device manufacturer located in Lenexa, KS. The report identified multiple significant deviations from regulatory requirements, many of which were repeat observations from a 2016 inspection.

Key issues included a lack of adequately established procedures for Corrective and Preventive Actions (CAPA), with the company failing to address previous FDA observations and external audit findings. The firm also lacked proper procedures for handling customer complaints, evidenced by an unrecorded 2018 complaint and insufficient investigation of other product defect claims. Furthermore, Splintek, Inc. failed to implement Unique Device Identifiers (UDI) on its SleepRight ProRx Custom Dental Guard labels, a violation of 21 CFR 801 Subpart B and 830. Additional deficiencies noted were the absence of established procedures for in-process and final acceptance activities, inadequate control of nonconforming products, a lack of management reviews since 1998, and insufficient internal quality audit records.

These observations indicate a systemic failure to maintain an effective quality management system as required by FDA regulations for medical device manufacturers. Splintek, Inc. is expected to respond to the FDA with a comprehensive plan of corrective actions to address all identified deficiencies and ensure ongoing compliance.