Writing Effective Deviation Investigations

Deviation investigations are a very common topic to be reviewed during FDA investigations.  Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit.  Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls. Proper root cause analysis of the issue is necessary to make sure that the firm is focusing on the real problem and subsequently the proper corrective and preventative actions can begin.