Sun Pharma's Dadra unit was slapped with a warning letter from the United States Food and Drug Administration (USFDA) last month. CNBC-TV has now accessed this warning letter, which highlights multiple repeat observations leading to strict regulatory action.
The warning letter noted repeated violations, including inadequate oversight and control over the manufacturing of drugs. Additionally, findings suggested that the drugmaker does not operate an effective quality system.
The company also failed to clean, maintain, and sanitize equipment at appropriate intervals and investigate unexplained discrepancies in a batch or its components, the warning letter stated.
Also Read | Sun Pharma gets USFDA warning for manufacturing practice violations at Dadra unit; stock extends fall
The US drug regulator had inspected Sun Pharma's Dadra unit back on December 4-15 last year, following which, it classified the facility as 'Official Action Indicated.'
The US FDA classifies a facility as OAI when it finds serious compliance issues, which, if not resolved, could lead to the unit facing export, regulatory, or administrative curbs.
Such has been the case for Sun Pharma, as the drugmaker did not rectify the observations marked by the US FDA, resulting in the issuance of the warning letter.
Shares of Sun Pharma have also been muted in the last three months, falling over 6 percent.
Also Read | Another regulatory blow for Sun Pharma after Dadra unit tagged 'OAI' by US FDA, stock down
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