The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.
There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.
The doctor struggles to understand how the observation extracted from the warning letter referenced in this week’s guidance managed to rise to the level of a Form 483 Observation.
There really is no excuse for receiving a Form 483 observation for management review.
Simply stated, an inspection needs to add some value; otherwise, what’s the point?
It is Dr. D’s humble opinion that the execution of an effective internal audit program falls into the basic blocking and tackling bucket.
Do not be the organization that fails to perform the audits and attempts to correct the issue after FDA arrives.
There is no such thing as minimum or maximum compliance—there is just compliance.
As finished devices become more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product.
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”