Form 483 re­veals qual­i­ty con­trol ques­tions and lack of train­ing at Sun Phar­ma’s plant in In­dia

The FDA has lift­ed the cov­ers on an­oth­er drug man­u­fac­tur­ing fa­cil­i­ty in In­dia re­cent­ly, re­veal­ing sev­er­al con­cerns around san­i­ta­tion and im­prop­er con­trols, among oth­er in­frac­tions.

Sun Phar­ma last month re­ceived a Form 483 from the agency, with 10 ob­ser­va­tions for the fa­cil­i­ty in Halol, In­dia, a small city in the west­ern por­tion of the sub­con­ti­nent.

Ac­cord­ing to the 483, fol­low­ing an in­spec­tion from April 26 to May 9, the FDA iden­ti­fied ob­ser­va­tions in­clud­ing de­fi­cient pro­ce­dures to pre­vent mi­cro­bi­o­log­i­cal con­t­a­m­i­na­tion of drugs, as well as de­fi­cient asep­tic pro­cess­ing ar­eas for mon­i­tor­ing en­vi­ron­men­tal con­di­tions and equip­ment and uten­sils not be­ing cleaned or san­i­tized at ap­pro­pri­ate in­ter­vals.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER