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

During an inspection from June 17-21, 2024, the FDA identified significant manufacturing deficiencies at Wild Child Laboratories Pty Ltd., an Over-the-Counter (OTC) drug manufacturer in Osborne Park, Western Australia. The inspection revealed multiple violations of regulatory standards, primarily concerning production and process controls, quality unit operations, and product testing.

Key issues included the firm's failure to establish adequate written procedures for manufacturing process validation across numerous OTC drug products, ensuring their identity, strength, purity, and quality. The quality control unit was found not to be fully following its responsibilities, evidenced by a lack of investigation into out-of-specification (OOS) results for bulk products and insufficient handling of customer complaints. Furthermore, the stability program for drug products lacked meaningful stability-indicating test methods, failing to assess degradation or impurities over the products' expiry periods.

Investigations into manufacturing discrepancies and OOS results were deemed inadequate, often not extending to other affected batches or fully assessing the impact on finished products. Equipment cleaning validation studies were not performed for non-dedicated manufacturing equipment, raising concerns about cross-contamination. Finally, finished drug product release testing was insufficient, lacking essential assay and content uniformity tests, and procedures to prevent objectionable microorganisms, like Burkholderia Cepacia, in non-sterile drug products were absent. Wild Child Laboratories is required to address these serious observations to ensure compliance with good manufacturing practices.