Received a 483? The Clock is Ticking.

If your company has ever received a 483 from FDA, you likely had a ton of questions about how to respond, how to make things right, and fast.  With new agency enforcement policies in action since 2009, companies are expected to respond to 483s within 15 business days.  What’s the best format for reporting back to FDA? How will a company know if its response is thorough enough? David Elder, who works in strategic compliance consulting at PAREXEL International, answers these questions in a recent issue of Pharmaceutical Technology. Elder is a former senior official with FDA.

“It has always been in a company’s interest to respond in writing to an FDA–483, List of Inspectional Observations, issued at the conclusion of their inspection. In so doing, the inspected company demonstrates to FDA that it understands the inspectional observations and that it is committed to implementation of corrective and preventive action. A thoughtful, complete, and timely response establishes credibility with FDA.” Read the rest of his response here.