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Talk to a SpecialistTalk to a SpecialistNatural Beauty Care Pty Ltd, an Australian manufacturer of over-the-counter drug products, failed to conduct adequate finished product testing required under current good manufacturing practice (CGMP) regulations. The company did not perform analytical assay testing for active ingredients on each batch of finished drug products before releasing them for distribution to the U.S. market, violating 21 CFR 211.165(a) and rendering the products adulterated. Without batch-level testing to confirm identity and strength of active ingredients, the company had no scientific evidence that its drug products conformed to required specifications prior to release.