Form 483 re­veals spore con­t­a­m­i­na­tion at a South Ko­re­an man­u­fac­tur­ing site last year

An FDA in­spec­tion found sev­er­al is­sues in­clud­ing spore-re­lat­ed con­t­a­m­i­na­tion in the man­u­fac­tur­ing area at a site in the city of Chun­cheon, South Ko­rea.

The in­spec­tion took place be­tween Aug. 12 and Aug. 20 last year at the NO. 2 fac­to­ry for Hugel, a mak­er of bot­u­linum tox­in(s), der­mal fillers and oth­er aes­thet­ic prod­ucts. The in­spec­tion it­self found sev­er­al ma­jor ob­ser­va­tions at the site in FDA doc­u­ments that were dis­closed on Tues­day.

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