How To Avoid Making FDA Inspectors Suspicious Or Angry

Over the past few years, the FDA has increased efforts to inspect manufacturing facilities. Some of the biggest drugmakers have encountered visits from inspectors at various sites; compound pharmacies are under heightened scrutiny after the fungal meningitis outbreak and inspection staff is being bolstered to improve oversight at foreign plants, such as in Asia (back stories here, here and here). But what happens when there is pushback? You know, a drugmaker hems and haws at making facilities or documents available, or the drugmaker prevents an inspector from accessing certain rooms or the premises altogether. In regulatory parlance, this is a no-no and can cause the FDA to declare that the drugs made at the facility are adulterated. Of course, procrastination and lack of cooperation is generally an invitation for heightened agency interest and may well lead to any number of regulatory measures. But the FDA wants drugmakers to know how to avoid such a scenario. And so, the other day, the agency issued a draft guidance that clearly spells out the circumstances that could cause trouble. Some of this is common sense, but just so everyone is clear, this is what the FDA says about a delay in a pre-announced inspection that can prompt a drug to be considered adulterated: A facility will not agree to a proposed inspection start date and does not give a reasonable explanation for its failure to do so; or after scheduling an inspection, a facility requests a later start date without g...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs