Dr. Reddy’s, Torrent Pharma and Laurus Synthesis all land Form 483 letters following FDA inspections

In De­cem­ber the FDA hit In­dia-based Tor­rent Phar­ma­ceu­ti­cals, Lau­rus Syn­the­sis and Dr. Red­dy’s Lab­o­ra­to­ries each with Form 483 let­ters pub­lished on Dec. 28. This was Dr. Red­dy’s sec­ond let­ter for the same fa­cil­i­ty in just two months.

In the lat­est 12-page let­ter for Dr. Red­dy’s site lo­cat­ed at Telan­gana, In­dia, the FDA not­ed in de­tail three ob­ser­va­tions found be­tween Dec. 4 and Dec. 8. The first Form 483 for the gener­ic drug gi­ant fol­lowed an in­spec­tion in Oc­to­ber.

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