FDA WARNING_LETTER - Wild Child WA Pty Ltd. - May 31, 2019

The FDA inspected Wild Child WA Pty Ltd. in Malaga, Australia, from May 27-31, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a)):** The firm released OTC drug products to the U.S. market without adequately testing the identity and strength of the active ingredient, using an inferior analytical method and omitting the minimum fill test specified in USP. The firm's response was inadequate as it only applied to future batches and lacked evaluation of distributed batches. 2. **Inadequate production and process controls (21 CFR 211.100(a)):** The firm lacked an adequate ongoing program for monitoring process control and did not provide documentation of process validation for OTC drug products. Batches were manufactured using significantly different parameters. The firm's response was inadequate, lacking sufficient detail, timelines, and protocols for validation activities. 3. **Failure to verify identity of components (21 CFR 211.84(d)(1)):** The firm failed to test incoming components for identity, relying on supplier COAs. The firm's response was inadequate, lacking documentation or timelines for implementing identity testing