Avoid an FDA Warning Letter

A Letter You Don’t Want to Receive

Here’s a quote from a recent FDA Warning Letter after an FDA inspection of a facility…

“You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.”

“Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.”

This is not a good day if you are the Director of Site Operations or the Quality Manager.

How To Avoid This Type of Letter

How can you avoid an FDA warning letter at your site? The answer is simple. You need an advanced root cause analysis system, and you need to apply it consistently both reactively and proactively.

Where can you learn advanced root cause analysis techniques to stop pharmaceutical quality issues?

Easy. Attend a 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Course. When and where are our public courses? CLICK HERE to find out.

Or sponsor a course at your site. CLICK HERE to contact one of our Implementation Advisors to get a quote for an on-site 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Course. Or call 865-539-2139.