Drug man­u­fac­tur­ers must sub­mit re­ports on qual­i­ty prob­lems to FDA. Al­most half of sites still don't, new re­port finds

The FDA’s post­mar­ket reg­u­la­tions re­quire that drug man­u­fac­tur­ers no­ti­fy the agency about any sig­nif­i­cant prod­uct qual­i­ty de­fects in mar­ket­ed prod­ucts with­in three work­ing days.

The re­ports, known as Field Alert Re­ports (FARs), are cru­cial for the agency to root out man­u­fac­tur­ing is­sues that can cause re­calls or lead to harm.

But a new re­port from the agency found that of the 1,143 man­u­fac­tur­ing sites that were el­i­gi­ble to sub­mit a FAR  from 2018 to 2021, al­most half (49%) of the sites did not sub­mit a re­port.

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