When Risk is Not an Option: A Look at FDA 483's

As pharmaceutical manufacturers continue to develop new technologies and processes become more complex, it's critical to understand the most common regulatory findings to assess and manage risks. Did you know you can you view inspection observations from the Food & Drug Administration (FDA) to help you manage your risks? The FDA’s Office of Regulatory Affairs (ORA) inspection observations are listed on an FDA Form 483. Take a glance at the number of some of their risk findings dating through 2015 for cleaning and microbial control industries at the link below.

Download Technical Tip