FDA 483 - Neutraderm Inc. - December 09, 2022

Neutraderm Inc. in Chatsworth, CA, an OTC manufacturer, received a Form 483 with six observations during an inspection from December 5-9, 2022. The observations primarily concern deficiencies in equipment cleaning and maintenance, calibration procedures, documentation of cleaning logs, sanitization procedures, quality control unit oversight, and the lack of established hold time studies for bulk drug products. These issues indicate significant concerns regarding the firm's adherence to CGMP for ensuring drug product quality and purity.