FDA EIR - Torax Medical, Inc. - February 20, 2020

An FDA inspection of Torax Medical, Inc., a Class III medical device manufacturer in Shoreview, MN, was conducted from February 11 to February 20, 2020. This comprehensive QSIT (Quality System Inspection Technique) Level II inspection evaluated the firm's management and design controls, CAPA, complaints, and production processes, guided by Compliance Program 7382.845 for medical device manufacturers and relevant Medical Device Reporting guidance.

While no FDA Form 483 was issued, two verbal observations were discussed. First, Torax Medical submitted six serious injury Medical Device Reports (MDRs) beyond the 30-day regulatory timeframe mandated by 21 CFR 803.50(a)(1). These reports stemmed from literature articles concerning the LINX Reflux Management System, and the FDA challenged the firm's internal interpretation of the "awareness date." Management committed to reviewing and potentially modifying its procedures to ensure timely reporting.

The second observation noted that management with executive responsibility failed to conduct semi-annual quality system reviews in 2017 and 2018, a requirement of their own procedures (21 CFR 820.20(c)). This gap was attributed to the company's acquisition and staff changes. However, this issue was not listed on a Form 483, as the firm had already rectified it by consistently holding reviews in 2019 and establishing a 2020 schedule, though the importance of such oversight was reiterated.