FDA is­sues warn­ing let­ter to South Amer­i­can in­gre­di­ent man­u­fac­tur­er over da­ta prob­lems

A Brazil­ian in­gre­di­ent man­u­fac­tur­er was slapped with an FDA warn­ing let­ter re­lat­ed to al­leged elec­tron­ic da­ta and soft­ware sys­tem prob­lems.

The let­ter was sent to Nortec Quim­i­ca, an ac­tive phar­ma­ceu­ti­cal in­gre­di­ent man­u­fac­tur­er based north of Rio de Janeiro, in ear­ly De­cem­ber. The FDA let­ter laid out a hand­ful of da­ta is­sues found af­ter an Au­gust in­spec­tion of the fa­cil­i­ty.

Nortec Quim­i­ca did not have “sys­tem se­cu­ri­ty and ac­cess con­trol” over its elec­tron­ic da­ta and soft­ware sys­tems, the FDA said, with in­spec­tors not­ing over 100 delet­ed files in the “re­cy­cle bins” on sev­er­al com­put­ers. The FDA al­so not­ed mul­ti­ple delet­ed files had batch num­bers in the file names, the ab­sence of at­trib­uted in­di­vid­ual user­names and no pass­word sign-ins re­quired to get in­to its Win­dows op­er­at­ing sys­tem.

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