FDA 483 - Argenta US Manufacturing LLC - December 14, 2022
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An FDA inspection of TriRx Shawnee, LLC, an animal and human drug manufacturer, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate out-of-specification results and customer complaints, lacked adequate procedures to prevent microbiological contamination in sterile products, and did not properly test components for parenteral drugs. These issues indicate a serious lack of adherence to good manufacturing practices.
ID · 6f50f0bb-ae80-47bc-aeea-32adbf0905ad