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USFDA's warning letter continues to haunt Dr Reddy's even after 3 years

The latest Form 483 with 8 observations came as a clear setback for the company, which was hoping to complete the remediation without giving a scope for any more observations

Approval for generics drug up but US business shrinks for home firms
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B Dasarath Reddy Hyderabad
Exactly three years ago on November 5, 2015, Indian drug major Dr Reddy's Laboratories Limited had received a Warning Letter from the US Food and Drug Administration (USFDA) for the poor state of affairs in three of its manufacturing facilities. 

The close-out letter from the USFDA continues to elude the company even after three years of remediation in the wake of latest round of concerns raised by the FDA inspectors regarding its Oncology formulations facility at Duvvada in Visakhapatnam. 

The Mohali plant of Sun Pharma was the only other recent example that comes close to this situation. The USFDA had