FDA inspections back up to speed, except those now deemed unnecessary

During much of the last two years, due to the COVID-19 pandemic and the movement restrictions that were imposed, US Food and Drug Administration inspections of manufacturing facilities were seriously limited and resulted in a large number of delays in new drug approvals.

However, according to Hyman, Phelps & McNamara lawyer Douglas Farquhar, the hold-ups are pretty much over. He said that, “those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID.”

That impression was corroborated this week at the GMP by the Sea conference when Douglas Throckmorton, Deputy Director for Regulatory Programs at the FDA’s Center for Drug Evaluation and Research, stated that domestic FDA inspections of facilities have been performed at “standard operational levels” since October 2021. He added that FDA’s foreign offices have also resumed performing inspections for nearly six months now, except in China, where Zero-COVID policies complicate logistics and scheduling.