FDA 483 - Dercher Enterprises, Inc., DBA Gordon Laboratories - May 04, 2021

Dercher Enterprises, Inc., DBA Gordon Laboratories, an Upper Darby, PA drug manufacturer and repacker, was cited for significant deficiencies in its quality system. The inspection revealed failures in thoroughly investigating out-of-specification results and microbiological contamination, inadequate process and cleaning validations, and a lack of robust stability and raw material testing programs. These issues indicate a systemic failure to ensure drug product quality, purity, and identity.