FDA WARNING_LETTER - Polymer Technology Systems, Inc. - February 15, 2019

The FDA conducted an inspection of Polymer Technology Systems, Inc. (PTS Diagnostics) from January 28 to February 15, 2019, identifying significant violations for their in vitro diagnostic medical devices. The devices were found adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System Regulation (21 CFR Part 820). Specific QSR deficiencies included failures in production process control (21 CFR 820.70(a)), process validation (21 CFR 820.75(a)), design change validation (21 CFR 820.30(i)), purchasing controls (21 CFR 820.50), and corrective and preventive action procedures (21 CFR 820.100(a)). Additionally, the PTS Detect Cotinine System was deemed adulterated for lacking an approved premarket approval (PMA) and misbranded for not submitting a 510(k) notification, as its intended use and near-patient testing nature did not qualify for exemption. The firm's devices were also misbranded under 21 U.S.C. § 352(t)(2) due to failures in Medical Device Reporting (21 CFR Part 803), specifically not submitting malfunction reports within 30 days and having inadequate MDR procedures. Furthermore, PTS Panel Strips were misbranded for failing to submit required Reports of Correction and Removals within 10 working days (21 CFR Part 806.10). The FDA requires prompt corrective actions, a written response within 15 business days detailing steps taken, prevention plans, and a timetable for systemic issues. Failure to comply may lead to regulatory actions like seizure, injunction, civil penalties, and impact on federal contracts and device approvals.