FDA 483 - TR Equipment AB - December 07, 2023

An FDA inspection of TR Equipment AB, a medical device manufacturer in Tranas, Sweden, from December 4-7, 2023, revealed numerous deficiencies in their quality system. The firm lacked established procedures for critical areas such as medical device reporting, design controls (verification, review, validation), corrective and preventive actions, document control, and non-conforming product. Additionally, the company failed to submit UDI information for its shower trollies and did not properly maintain complaint files, indicating a broad systemic failure in regulatory compliance.