FDA 483 - Wild Child Laboratories Pty Ltd. - June 21, 2024

Wild Child Laboratories Pty Ltd. in Osborne Park, Australia, an OTC drug manufacturer, was cited for significant deficiencies in its quality control and manufacturing processes. The inspection revealed a lack of validated manufacturing processes, inadequate stability testing, and failures in investigating out-of-specification results and customer complaints. These issues indicate a systemic breakdown in ensuring drug product quality, identity, strength, and purity.