FDA 483 - Wild Child Laboratories Pty Ltd. - May 31, 2019

Wild Child WA Pty Ltd., an OTC Drug Product Manufacturer in Malaga, Australia, was inspected by the FDA from May 27-31, 2019. The inspection revealed significant deficiencies across its quality control, laboratory, production, and material systems. Key issues include a failure to investigate deviations, inadequate product testing, lack of process validation, and insufficient raw material identification, raising concerns about the quality and purity of US-marketed products.