FDA ships Form 483 to gener­ic drug gi­ant Dr. Red­dy’s due to equip­ment is­sues, oth­er ob­ser­va­tions

The FDA has is­sued a Form 483 let­ter to In­di­an gener­ic drug gi­ant Dr. Red­dy’s Lab­o­ra­to­ries, af­ter the agency found po­ten­tial­ly con­t­a­m­i­nat­ed drugs dur­ing an eight-day in­spec­tion from Oct. 19 at its site in Telan­gana, In­dia.

The 23-page let­ter cites nine ob­ser­va­tions, in­clud­ing poor­ly-cleaned equip­ment and dent­ed ma­chin­ery, caus­ing leak­ages and liq­uid spillages.

Residues of pre­vi­ous­ly man­u­fac­tured drug prod­ucts were found in man­u­fac­tur­ing equip­ment, lead­ing to po­ten­tial con­t­a­m­i­na­tion. The man­u­fac­tur­ers’ writ­ten spec­i­fi­ca­tions for test­ing aer­o­bic mi­cro­bial, yeast and mold counts for drug prod­ucts were al­so “de­fi­cient,” lead­ing to dis­crep­an­cies in colony counts, ac­cord­ing to FDA in­spec­tors.

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