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Talk to a SpecialistTalk to a SpecialistHuangshi Hygienic Material Medicine Co., Ltd., a Chinese pharmaceutical manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in its production of finished drug products. FDA inspectors found that the company failed to perform appropriate laboratory testing for identity and strength of active ingredients prior to batch release, with management acknowledging that approximately (b)(4) batches intended for the U.S. market were released without adequate finished product testing. This failure to conduct required release testing means the company lacked scientific evidence that each batch conformed to appropriate specifications before distribution, rendering the drug products adulterated under federal law.