News

At the beginning of August, the FDA issued a Warning Letter to a US company that had shown deficiencies in the areas of product and process control through to stability analysis during an inspection. The Warning Letter was a result of the company's inadequate response after receiving a 483 form following an FDA inspection.

A US company received a Warning Letter because of problems at their CMO. The FDA points out that companies are responsible for the quality of the drugs regardless of agreements in place with CMOs.

The Australian authority TGA now carries out shorter inspections under defined conditions, so-called "surveillance inspections". This applies to both domestic and foreign manufacturers.

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.