Jordanian OTC drug manufacturer receives FDA warning letter over multiple ‘unacceptable hazards’

Gener­ic drug man­u­fac­tur­er Am­man Phar­ma­ceu­ti­cal In­dus­tries has been is­sued an FDA warn­ing let­ter af­ter be­ing placed on sev­er­al im­port alerts, with in­spec­tors find­ing “fun­da­men­tal de­sign flaws” and “se­ri­ous da­ta breach­es” at its fa­cil­i­ty in Jor­dan’s cap­i­tal.

The FDA not­ed the fa­cil­i­ty had “un­ac­cept­able con­di­tions” which can lead to drug con­t­a­m­i­na­tion.

The warn­ing let­ter — hand­ed to Am­man on Feb. 14 — was pub­lished on Feb. 26. The man­u­fac­tur­er ships over-the-counter med­i­cines glob­al­ly, in­clud­ing to the US.

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