Luminex Corporation – FDA Warning Letter, Feb 14, 2020

The FDA issued a Warning Letter to Luminex Corporation following inspections from February 10-14, 2020, at their Austin, TX, and Northbrook, IL facilities. The inspections revealed that Luminex's VERIGENE Processor SP System is adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to report corrections or removals.

Key violations include: 1. **Failure to validate processes (21 CFR § 820.75(c)):** Luminex used heater fixtures from a new manufacturer for VERIGENE SP calibration since March 2019 without adequate validation, an approved plan, or a report, and without validating the new QC method. 2. **Inadequate CAPA procedures (21 CFR § 820.100(a)):** CAPA LMNX-CAPA-18-017, opened for false negative results with VERIGENE heat calibration fixtures, failed to document containment actions for distributed instruments serviced with inadequately validated fixtures. 3. **Inadequate servicing procedures (21 CFR § 820.200(a)):