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Talk to a SpecialistTalk to a SpecialistNingbo Poplar Daily-Use, an OTC drug manufacturer, failed to conduct adequate laboratory testing on finished drug products prior to release, including assay testing and required specification testing, instead relying only on a "Drug Facts Label" without proper finished product specifications. The facility violated Current Good Manufacturing Practice (CGMP) regulations under 21 CFR parts 210 and 211 by not demonstrating satisfactory conformance to final specifications for identity and strength of active ingredients before distribution. These manufacturing control failures rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.