FDA Insists Its Quality Controls Are Up To The Task

Allegations of substandard quality controls are not a new phenomenon for the generics industry. However, it is rare for an industry regulator to produce as comprehensive and pointed a response to such criticism as has just been published by the US Food and Drug Administration (FDA).

In a lengthy statement – apparently positioned as a rebuttal to media coverage suggesting deficiencies in the FDA’s quality oversight for generics facilities, both foreign and domestic – Scott Gottlieb...