FDA 483 - Pharmaron Manufacturing Services (US) LLC - January 23, 2020

Rhodes Technologies, an Active Pharmaceutical Ingredient manufacturer in Coventry, RI, was cited for a significant quality control issue. The firm's Quality Control Unit failed to adhere to its own written procedures for the release of bulk liquid nitrogen, a critical production material. This involved a failure to properly complete required documentation and ensure QC Director confirmation of test results before material release.