Loading…
Terragene S.A., an Argentina-based manufacturer of Biological and Chemical Sterilization Process Indicator Systems, was found to produce adulterated medical devices that failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The FDA inspection conducted in June 2023 identified failures to establish adequate complaint handling procedures, specifically noting that the firm's procedures did not ensure complaints were received, reviewed, and evaluated in a uniform and timely manner as required by 21 CFR 820.198(a)(b). The company's violations stemmed from deficient manufacturing, packing, storage, or installation controls that did not meet Quality System regulation standards.