FDA WARNING_LETTER - Yangzhou H&R Plastic Daily Chemical Co., Ltd. - October 24, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd., following an inspection conducted from October 21 to 24, 2025. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering the company"s drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key issues included the firm"s failure to adequately test finished drug products for active ingredient identity and strength before release, insufficient identity testing of incoming raw materials, and reliance on unvalidated supplier certificates of analysis. Additionally, the company lacked established procedures for production and process control, including equipment qualification, process validation, and ongoing monitoring for consistent drug quality. The quality control unit also failed to effectively oversee manufacturing operations, specifically regarding stability programs, batch record completeness, and packaging material verification.

To address these serious deficiencies, the FDA mandates comprehensive actions. These include independent assessments of laboratory and material systems, full testing of retain samples for all in-expiry distributed products, and robust process validation plans. The firm must also enhance its quality control unit"s authority and resources. The FDA strongly recommends engaging a qualified CGMP consultant to audit operations and guide compliance efforts. Due to these violations, the FDA has placed the firm"s drugs on Import Alert 66-40, prohibiting their entry into the U.S. market until compliance is verified. A written response detailing corrective actions is required within 15 working days.