FDA restarts do­mes­tic drug man­u­fac­tur­ing in­spec­tions

Af­ter a pause of 41 days, the FDA restart­ed its do­mes­tic phar­ma-re­lat­ed sur­veil­lance in­spec­tions on Mon­day.

That de­ci­sion to restart, which came as a re­sult of the steep de­cline in Covid-19 cas­es across the coun­try, fol­lowed the agency’s pre­vi­ous de­ci­sion to pause these do­mes­tic in­spec­tions in De­cem­ber.

“In ad­di­tion to the re­sump­tion of plan­ning and con­duct­ing do­mes­tic sur­veil­lance in­spec­tions on Feb. 7, the FDA con­tin­ues to con­duct both for­eign and do­mes­tic mis­sion-crit­i­cal in­spec­tions, as well as pro­vide ef­fec­tive over­sight of foods, drugs, med­ical prod­ucts and to­bac­co lever­ag­ing a va­ri­ety of tools, in­clud­ing re­mote as­sess­ments. The agency al­so con­tin­ues to pro­ceed with pre­vi­ous­ly planned for­eign sur­veil­lance in­spec­tions that have re­ceived coun­try clear­ance and are with­in the Cen­ter for Dis­ease Con­trol and Pre­ven­tion’s Lev­el 1 or Lev­el 2 COVID-19 trav­el rec­om­men­da­tion,” FDA said Fri­day.

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