Dr. D Sees a Trend
There really is no excuse for receiving a Form 483 observation for management review.
Tag Archives: Form 483s
Responding to a Warning Letter
So your organization has received a warning letter from FDA – now what? For starters, the agency has quickly upped the ante in regards to taking the next steps in ensuring your organization clearly understands that a continued state of non-compliance is not acceptable. Warning letters are life-changing events for device manufacturers; however, they are recoverable. Dr. D recommends getting legal counsel and industry experts involved when responding to a warning letter, reviewing subsequent correspondence…
Responding to a Form 483
There are two options in regards to Form 483s: in option One, an organization can be proactive, accept the Form 483, and treat is as an opportunity for pursuing continuous improvement, while driving compliance to the QSR. In option Two, an organization can ignore the Form 483, and in doing so, be prepared to deal with the proverbial opening of the can of “FDA worms” and the subsequent warning letter that will be issued.
