An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug man­u­fac­tur­ing site in In­dia has once again land­ed in the crosshairs of FDA in­spec­tors.

The fa­cil­i­ty in ques­tion is Cipla’s drug man­u­fac­tur­ing fa­cil­i­ty in the vil­lage of Ver­na, in the state of Goa in In­dia’s south­west. In a sign that for­eign in­spec­tions might ramp up again, the FDA’s vis­it from Aug. 16 to Aug. 22 un­cov­ered six ob­ser­va­tions.

The 11-page re­port not­ed that en­vi­ron­men­tal mon­i­tor­ing at the site did not prop­er­ly en­sure that mi­cro­bial con­t­a­m­i­nants were not mak­ing any im­pact in the asep­tic fill­ing ar­eas. It al­so found that pro­ce­dures meant to stop mi­cro­bial con­t­a­m­i­na­tion were not ad­e­quate­ly con­duct­ed in asep­tic ar­eas of the fa­cil­i­ty.

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