Dr Reddy's Labs Secures USFDA Nod for Srikakulam Facility
Dr Reddy's Laboratories has received an establishment inspection report from the USFDA for its Srikakulam facility. The report classifies the site as 'Voluntary Action Indicated', meaning no immediate regulatory action will follow despite noted issues.
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- India
In a significant development, Dr Reddy's Laboratories announced the receipt of an establishment inspection report from the US Food & Drug Administration for its manufacturing facility located in Srikakulam, Andhra Pradesh. Classifying the facility with a 'Voluntary Action Indicated' status, the USFDA's report marks a critical regulatory milestone.
The inspection, which included a GMP and a Pre-Approval Inspection, was conducted by the US regulatory body at Dr Reddy's FTO 11 formulations manufacturing site. This completion was formally communicated to market exchanges on July 18, 2025, underscoring the company's regulatory transparency.
The USFDA's designation of 'Voluntary Action Indicated' implies that although the inspection unearthed some objectionable conditions, the agency does not foresee any immediate regulatory measures being taken. This closure of inspection provides Dr Reddy's Laboratories with the opportunity to address noted issues proactively.
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