 "Dr Reddy's")
Dr Reddy's Laboratories on Monday announced that they received a Voluntary Action Indicated (VAI) status from the United States Food and Drug Administration (USFDA) following an inspection of its research and development (R&D) centre for Integrated Product Development Organisation (IPDO) in Bachupally, Hyderabad.
Last year in December, during the Good Manufacturing Practice (GMP) and Pre-Approval Inspection at the same facility concluded with three observations.
This marks the second such outcome in recent weeks for the company, following VAI status granted to its largest formulations manufacturing plant (FTO-3) in Bachupally, Hyderabad earlier in February.
An overview of the recent inspections includes last year’s Good Manufacturing Practice (GMP) inspection in June for the Active Pharmaceutical Ingredient (API) manufacturing facility in Bollaram, Hyderabad (CTO-3), which concluded with an outcome of zero observations.
In the same year in July, a Pre-Approval Inspection (PAI) and routine GMP inspection at the API manufacturing facility in Srikakulam, Andhra Pradesh (CTO-6) resulted in zero observations.
However, on 16 October, during a product-specific PAI at the biologics manufacturing facility in Hyderabad, the inspection concluded with nine observations. In response, the company has taken proactive measures to address and resolve these observations in collaboration with regulatory authorities.
Similarly, on 28 October, during a routine Current Good Manufacturing Practice (cGMP) inspection at the formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad, the facility was given ten observations.
In the same year in December, during the GMP and Pre-Approval Inspection at the R&D centre (IPDO) in Bachupally, Hyderabad, which concluded with three observations, this inspection marks the latest success as it received Voluntary Action Indicated (VAI) status, indicating no escalation in regulatory concerns.
