The Indian drug and ingredient firm announced the Form 483 in a filing on the Bombay Stock Exchange (BSE) on Tuesday, explaining that US Food and Drug Administration (FDA) had made three observations.
Dr Reddy’s told us the six day audit began last week but declined to comment on the nature of the US regulator's observations.
The Miryalaguda site produces APIs for a range of medicines – including treatments for cardiovascular diseases and cancer- for drug manufacturers supplying India and international markets.
The site was one of several Dr Reddy’s facilities criticized in a US FDA warning letter published in 2015.
At the time, inspectors said the firm had failed to investigate out-of-spec test results and also raised concerns about record keeping related to production equipment.
In addition, the FDA said Dr. Reddy’s had failed to prevent unauthorized access to quality control data.
In October, COO Abhijit Mukherjee told analysts the problems had been resolved but not reassessed during Dr. Reddy’s fiscal Q2 earnings call.
He said: “On the quality front, we’re actively focusing towards universal compliance of the global quality management systems, specific to the three Warning Letters affected sites, we have addressed all the commitments and the awaited session by FDA."
Mukherjee reiterated this position during the Q3 call earlier this month.
“Our warning letter impacted sites are scheduled to get re-audited during the months of February and March. Substantial remediation work has been put in place from our side."
"Our application of corrective and preventative actions, or CAPAs, was not just site specific but also network wide” he continued, adding that the measures had involved third party reviews and assessments.