In order to ensure the safety, efficacy and quality of therapeutic products, FDA is responsible for conducting both pre- and post-approval inspections to enforce compliance with applicable regulations and quality standards. The instrument with which FDA officially notifies firms of objectionable findings and potential violations is the form FDA 483 (483), which was put in place to assure that firms receive proper notice prior to any actions undertaken against them by the agency. This legislation also requires that firms receive official written notice of inspection prior to the conduct of any such enforcement activities.
While it is clear that the purpose of the 483 is to list and document objectionable conditions disclosed during FDA inspections, it also serves to assist companies in the remediation of their nonconformities. In 2009, new and enhanced federal enforcement strategies were implemented by Congress requiring that firms submit all post-inspection 483 responses to FDA within 15 working days of receipt. Failure to comply with this mandate results in the issuance of a Warning Letter.
Upon completion of the course, you will have a full and balanced understanding of the notification of findings (483) process, and how to effectively prepare a sound and strategic response toward a favorable outcome with minimal risks.
During this interactive session, we will discuss:
- Why your organization might receive a 483
- How to minimize your chances of receiving a 483
- Recourses upon receipt of a 483 from the inspector
- Best practices for responding to a 483
- A 5 year horizon in 483 metrics and trends – a look backward and forward