FDA 483 - Phoenix Wipes Inc - December 19, 2023

Phoenix Wipes Inc, an OTC manufacturer in West Babylon, NY, received a Form 483 with nine observations during an inspection from December 4-19, 2023. The observations primarily highlight significant deficiencies in their quality control unit, equipment qualification, process validation, component testing, stability data, annual product reviews, employee training, and record-keeping practices. These issues indicate a lack of established and followed CGMP-compliant procedures for drug product manufacturing and control.