FDA 483 - CofixRX, LLC - January 20, 2023

CofixRX, LLC in Rochester Hills, MI, was inspected and received a Form FDA 483 with six observations. The inspection revealed significant deficiencies across multiple quality system areas, including the absence of a quality control unit, lack of stability testing, and inadequate complaint investigations. These issues indicate a fundamental lack of established procedures and oversight for drug product manufacturing and distribution.