Sun Phar­ma fa­cil­i­ty un­der an im­port alert hand­ed a warn­ing let­ter

A man­u­fac­tur­ing site be­long­ing to a ma­jor gener­ics man­u­fac­tur­er in In­dia has been giv­en a warn­ing let­ter from the FDA af­ter it was placed on an im­port alert.

The FDA’s let­ter, which was sent on Dec. 15, in­volves a 23-page Form 483 in­spec­tion in April and May of last year and its sub­se­quent re­sponse by Sun Phar­ma.

Dur­ing the FDA’s ini­tial in­spec­tion, sev­er­al vi­o­la­tions were not­ed, which in­clud­ed not ac­cu­rate­ly sim­u­lat­ing com­mer­cial op­er­a­tions and “poor asep­tic tech­niques.” These tech­niques in­clud­ed an op­er­a­tor in­sert­ing a gloved hand in­side a can­is­ter, some­one touch­ing the “prod­uct con­tact sur­face” of a stop­per be­fore plac­ing it back in­to a can­is­ter, and move­ments from the op­er­a­tors in “crit­i­cal ar­eas” not al­ways be­ing slow and de­lib­er­ate, among oth­ers.

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