News

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Vietnam following an inspection that uncovered several significant violations of Current Good Manufacturing Practice (CGMP) regulations. These violations include the failure to conduct proper laboratory testing for drug batches, inadequate testing to verify the identity of components, assigning expiration dates without scientific justification, and a lack of sufficient quality control measures.

The FDA carried out an inspection at Jiangsu Hengrui in January 2024. Initial results have now been published in a so-called Form 483. The number and severity of the observations is alarming.

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese company based on a review of records. Key issues include failure to adequately test the identity of incoming components, lack of process validation, and inadequate laboratory testing of finished drug products.

The FDA rarely goes into great detail about expected measures in its Warning Letters, especially not when it comes to instructions on the desired procedure. This is now different in a Warning Letter that was published in July. It describes in considerable detail what the FDA considers to be appropriate CAPA measures in a specific case.