Latest News - 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 to clear a re-audit after the company had invited the FDA to do a fresh evaluation of all its three facilities that were issued a warning letter in November 2015, over lapses in what are termed “Current Good Manufacturing Practices”.
The company recently announced that all the commitments as part of the earlier warning letter response had been completed. The latest observations will further prolong the regulatory scrutiny at these.
Last month, the US regulator issued a (Read More)
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