Cipla man­u­fac­tur­ing site in In­dia lands a Form 483 for un­clean equip­ment, lack of da­ta

While sev­er­al ma­jor In­di­an phar­ma­ceu­ti­cal man­u­fac­tur­ers have been cit­ed by the FDA this year, it ap­pears that Cipla is the lat­est to re­ceive a Form 483 fol­low­ing an in­spec­tion from the US reg­u­la­tor.

Ac­cord­ing to the FDA, which in­spect­ed the man­u­fac­tur­ing site out­side of the city of In­dore, In­dia, be­tween June 27 and Ju­ly 7 of this year, the fa­cil­i­ty was not cleaned and main­tained at cor­rect in­ter­vals to pre­vent con­t­a­m­i­na­tion that could al­ter the safe­ty of drug prod­ucts.

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