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Talk to a SpecialistTalk to a SpecialistGFA Production Xiamen Co., Ltd., a Chinese drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in June 2024 following an FDA inspection in December 2023. The company failed to establish adequate written procedures for production and process control to ensure drug products met required identity, strength, quality, and purity standards, and critically lacked process validation data—providing only equipment qualification reports instead of the necessary process performance qualification (PPQ) data with sufficient detail, justification, and sampling plans. These deficiencies rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.