Warning Letter issued to Chinese OTC Manufacturer: Violations of Current Good Manufacturing Practice (CGMP) regulations

On March 26, 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese manufacturer operating a U.S.-registered facility, known for producing over-the-counter (OTC) drug products like Antibacterial Hand Sanitizer. Following a review of submitted documents, the FDA highlighted significant violations of Current Good Manufacturing Practice (CGMP) regulations. These violations include inadequate testing of incoming components like ethanol for methanol contamination, insufficient testing of finished drug products before release, and a lack of a comprehensive stability testing program for the hand sanitizer. The Quality Unit (QU) also failed to oversee manufacturing quality effectively. The FDA recommended hiring a qualified consultant to address CGMP requirements before resuming operations and emphasized the need for prompt corrective action to prevent further regulatory measures. The complete Warning Letter to Deqing Jiarou Daily Chemical Co., Ltd. is available on the FDA website.