Sammy Seligman, & Dr. John Lu
Good manufacturing practices are essential to the drug industry. One method to check adherence to these practices is to inspect the manufacturing sites where the drugs are made. In the United States, the FDA is responsible for conducting these inspections of sites that manufacture drugs sold. Unsatisfactory findings are noted when the FDA issues an Official Action Indicated (OAI) letter to the manufacturing company for the site that is not in compliance. Here, we present our findings for manufacturing firms from the years 2015-2019 from common manufacturing countries including China, India, Italy, and the United States. Using available data from the FDA, we hope to show a correlation between the number of OAIs issued per site per country and the overall drug quality being manufactured. This work aims to bring to light the importance of quality and adherence to good manufacturing practices to ensure that patients around the world receive drugs that are safe and effective.