USFDA inspection at Solara’s Cuddalore facility concludes with Zero 483 observations

Solara Active Pharma Sciences announced that its multiproduct manufacturing facility at Cuddalore, completed successfully the inspection carried out by the US Food and Drug Administration (US FDA). USFDA inspected the Cuddalore facility between July 31, 2023 – August 04, 2023. The inspection established that the facility is in an “Acceptable State of Compliance” with Zero Form 483 inspectional observations from the Agency.

With this successful inspection outcome, the current inspection classification of Cuddalore site shall be reinstated to NAI (No Action Indicated).

This facility has also successfully completed the regulatory inspections carried out by the World Health Organization (WHO) between January 23 – 26, 2023 and EU-GMP Inspection carried out jointly by the State Institute for Drug Control (SUKL), Ministry of Health of the Czech Republic and National Authority of Medicines and Health Products (INFARMED), Portugal between February 07 – 09, 2023.

Poorvank Purohit, MD and CEO, commented, “We are happy with the outcome of the FDA inspection with Zero 483 inspectional observations. This is the third consecutive successful regulatory inspections outcome (USFDA, EU-GMP and WHO-GMP inspections) at our Cuddalore site and gives us confidence in our quality systems and oversight of our manufacturing infrastructure. The result of these inspections demonstrates our commitment to regulatory excellence at our global manufacturing sites and our relentless focus on world-class quality and compliance. We stay committed to exhibit the highest level of compliance and constant focus on world-class quality with the validated quality systems established across Solara’s manufacturing network.

The Cuddalore multi-product API manufacturing facility was established in the year 1991 and is equipped with appropriate infrastructure to include several independent production blocks and related packaging sections. This site is inspected by various regulatory authorities including US FDA, MHRA, EDQM, WHO, PMDA, TGA, KFDA, and COFEPRIS.