A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pan­dem­ic con­strained the FDA’s abil­i­ty to trav­el for on­site man­u­fac­tur­ing in­spec­tions, the agency in­creas­ing­ly turned to re­quest­ing records to fill the gap, even for hun­dreds of US-based fa­cil­i­ties.

FDA ex­plains in its guid­ance on man­u­fac­tur­ing in­spec­tions dur­ing the pan­dem­ic that the agency can re­quest records (not to be con­fused with the FDA’s re­mote in­ter­ac­tive eval­u­a­tions) di­rect­ly from fa­cil­i­ties “in ad­vance of or in lieu of” cer­tain on­site in­spec­tions. Com­pa­nies are legal­ly re­quired to ful­fill those re­quests be­cause a de­nial may be con­sid­ered lim­it­ing an in­spec­tion, which could lead to the FDA deem­ing a drug made at that site to be adul­ter­at­ed.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.