Novugen Pharma Malaysia Achieves Zero Form 483 Citations in Recent USFDA Audit

 Novugen Pharma Sdn. Bhd. is pleased to announce the successful completion of a surveillance inspection audit conducted by the U.S. Food and Drug Administration (USFDA) from 21st to 25th of October 2024. The company proudly reports that it completed the five-day audit with zero Form 483 citations and no deficiencies.

According to the surveillance inspection, Novugen demonstrated a state of good control from a Good Manufacturing Practice (GMP) compliance perspective. Achieving the status of NAI (No Action Indicated) is a significant milestone for Novugen, representing the highest level of compliance attainable by any USFDA-registered manufacturing facility. This unique accomplishment, alongside the zero Form 483 citations, positions Novugen among a select few global companies that meet this standard.

“We are incredibly proud of this achievement, which reflects the relentless dedication, hard work, and culture of continuous improvement fostered by the entire Novugen team in maintaining the highest standards in pharmaceutical manufacturing,” said Rahil Mahmood, Chief Executive Officer of Novugen. “This milestone reinforces our position as a trusted player in the global pharmaceutical industry.”

The audit is not only a regulatory requirement for Novugen’s continued operations in the USA, but it also underscores the company’s commitment to quality and the strategic investments made in Malaysia to thrive in highly regulated markets. Quality is embedded in Novugen’s DNA, enabling the company to confidently showcase its strength, resilience, and commitment to excellence.

Novugen remains dedicated to delivering high-quality pharmaceutical products and advancing healthcare solutions that benefit patients around the world.