12/13 September 2024
On 26 March 2024, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter dated 18 March 2024 to a Chinese manufacturer. The facility is registered in the United States and produces of over-the-counter (OTC) drug products, including Antibacterial Hand Sanitizer.
The Warning Letter is based on a review of documents submitted in response to an official request for records and other information.
The Warning Letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, including the following:
The FDA recommends engaging a qualified consultant to assist in meeting CGMP requirements before resuming drug manufacturing operations. Additionally, the letter emphasizes the importance of promptly addressing and correcting the identified violations to avoid further regulatory actions.
For further information, please read the complete Warning Letter to Deqing Jiarou Daily Chemical Co., Ltd. published on the FDA website.