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In another setback to drug major Dr Reddy’s Laboratories’ (DRL’s) remediation effort, its oncology formulations facility at Duvvada in Visakhapatnam has got a long and adverse rap from the US Food and Drug Administration (FDA).
This particular rap is termed Form 483. The FDA issues it when an inspection of a unit reveals various objectionable deviations from its rules and standards. It was issued (“it has 13 observations, which we are addressing,” the company said, without details) after a new audit of the plant in question that was concluded on Thursday.
This is the second unit of Dr Reddy’s that has failed
