Last Updated on October 6, 2024 by The Health Master
Inspection by USFDA
Solara Active Pharma Sciences, a prominent pharmaceutical company, has recently announced a significant achievement for its multiproduct manufacturing facility located in Cuddalore, Tamil Nadu.
The facility has received a favorable outcome from the rigorous inspection conducted by the US Food and Drug Administration (USFDA).
This milestone underscores Solara’s commitment to maintaining high-quality standards and regulatory compliance in its operations.
Successful USFDA Inspection
The Cuddalore, Tamil Nadu, manufacturing facility underwent a comprehensive inspection by the USFDA, carried out over a span of several days, from July 31, 2023, to August 04, 2023.
The outcome of the inspection has been overwhelmingly positive, with the facility being deemed to be in an “Acceptable State of Compliance.”
Remarkably, there were zero Form 483 inspectional observations raised by the USDA, solidifying the facility’s dedication to maintaining stringent quality standards.
Reinstated Inspection Classification
The successful USFDA inspection has led to the reinstatement of the inspection classification of the Cuddalore, Tamil Nadu, site to NAI (No Action Indicated).
This reinstatement reflects the facility’s unwavering commitment to regulatory compliance and underscores its consistent efforts to uphold high standards.
Global Recognition and Approvals
The Cuddalore, Tamil Nadu, facility’s commitment to excellence extends beyond the USFDA inspection.
It has previously achieved successful regulatory inspections by renowned organizations:
World Health Organization (WHO):
The facility underwent a regulatory inspection by the WHO from January 23 to January 26, 2023.
EU-GMP Inspection:
In another significant achievement, the facility successfully completed an EU-GMP Inspection conducted jointly by the State Institute for Drug Control (SUKL), the Ministry of Health of the Czech Republic, and the National Authority of Medicines and Health Products (INFARMED), Portugal.
This inspection took place from February 07 to February 09, 2023.
CEO’s Perspective
Poorvank Purohit, the Managing Director and CEO of Solara Active Pharma Sciences, expressed his satisfaction with the successful USFDA inspection outcome.
He highlighted the absence of any Form 483 inspectional observations as a testament to the company’s quality systems and manufacturing oversight.
Purohit emphasized that this marks the third consecutive successful regulatory inspection at the Cuddalore, Tamil Nadu, site, instilling confidence in Solara’s dedication to quality and compliance on a global scale.
Manufacturing Excellence and Infrastructure
The Cuddalore, Tamil Nadu, multi-product API manufacturing facility, established in 1991, boasts robust infrastructure and numerous independent production blocks, alongside related packaging sections.
This facility has received inspections and approvals from various international regulatory bodies, including:
Solara’s relentless focus on regulatory excellence, world-class quality, and compliance is evident in its unwavering commitment to maintaining high standards across its global manufacturing network.
This achievement reaffirms Solara Active Pharma Sciences’ dedication to upholding the highest level of compliance and quality within the pharmaceutical industry.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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