News

In a Warning Letter addressed to a US-American pharmaceutical manufacturer, the FDA points out various deficiencies in aseptic production. Among other things, deficiencies are described in the design of equipment and rooms, airflow and visual inspection.

The U.S. Food and Drug Administration (FDA) has issued a warning letter to an American manufacturer of OTC drug products. Among others, the analytical test methods had not been validated for accuracy, specificity, and reproducibility. Further violations concern the process validation and OOS investigations.

The FDA is planning a programme to assess and classify manufacturing sites using surveillance data and company participation. A central point here is also the so-called Quality Culture.

Do you know the FDA Data Dashboard? This database offers comprehensive and detailed insights into FDA inspections - right down to the inspection history of individual companies.