Bot­u­lism risk: FDA de­liv­ers warn­ing let­ter to Gadal Labs for site mak­ing OTC pe­di­atric drugs 

Gadal Lab­o­ra­to­ries has re­ceived an FDA warn­ing let­ter be­cause of sev­er­al man­u­fac­tur­ing vi­o­la­tions that in­creased the risk of bac­te­r­i­al con­t­a­m­i­na­tion to its over-the-counter (OTC) drug prod­ucts.

The agency dis­cov­ered “sig­nif­i­cant” cGMP vi­o­la­tions by Gadal at an in­spec­tion of its Mi­a­mi fa­cil­i­ty last Feb­ru­ary, where the com­pa­ny al­so au­tho­rized the use of an un­named ac­tive in­gre­di­ent with­out check­ing its sup­pli­er’s cer­tifi­cate of analy­sis.

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