FDA Warning Letter Highlights Systemic Compliance Failures at Chinese Drug Manufacturer

On 24 March 2026, the U.S. Food and Drug Administration issued a Warning Letter dated 18 March, following an October 2025 inspection of Yangzhou H&R Plastic Daily Chemical Co., Ltd. The agency noted the firm failed to respond to earlier observations while continuing to export products to the U.S.

A key concern was the release of drug batches without adequate analytical testing. The company relied only on basic checks such as appearance, color, and weight, instead of conducting full testing for identity and strength of active ingredients.

The FDA also flagged weak controls over incoming materials, with insufficient identity testing and overreliance on supplier certificates. Additionally, the firm lacked proper equipment qualification and process validation, including absence of process performance qualification studies.

Serious gaps were identified in quality unit oversight, prompting FDA to recommend a comprehensive, systems-based remediation approach with external expert support.

08-04-2026