GMP News - Inspections/Audits

The U.S. Food and Drug Administration (FDA) pays close attention to what is inside hand sanitizer products imported into the United States. Recently, a product labeled as containing 75% ethanol, but in fact contained only 58%, was detained and refused admission at the border. As a consequence, the Chinese manufacturer received a Warning Letter.

With an updated Guidance document, the US Food and Drug Administration (FDA) plans to improve communication with industry.

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published an English version of a Procedure for Remote Inspections.

Due to the current pandemic and the associated restrictions, assessments are increasingly being performed remotely. Are these Distant Assessments also an option for the post-pandemic period?

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

The Swiss Agency for Therapeutic Products Swissmedic has published a press release clarifying the validity of GMP certificates during the COVID-19 pandemic.

Due to deficiencies in the ventilation system and particle monitoring in the sterile area, an Indian pharmaceutical manufacturer has recently received a Warning Letter from the U.S. FDA. In addition, the microbiology testing was also criticized.