• 22 Jul 2025
• Admin
• News Article

Bloomage Achieves FDA GMP Audit with Zero-Deficiency, Reinforcing Global Trust

Overview

Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, has announced it successfully passed the U.S. Food and Drug Administration (FDA)'s on-site GMP audit with a ""No Action Indicated"" (NAI) result. This is the best possible result, confirming complete compliance with no objectionable conditions (""zero-deficiency"").
The FDA's issuance of a Current Good Manufacturing Practice (CGMP) compliance notification and Establishment Inspection Report (EIR) formally recognizes Bloomage's pharmaceutical quality system as fully aligned with international regulatory expectations. The recognition not only affirms Bloomage's commitment to excellence in quality management but also significantly strengthens its position in global markets, providing international partners and customers with added confidence.

FDA Certification: The Global Gold Standard for Pharmaceutical Quality

• The FDA is widely recognized as one of the most rigorous drug regulatory agencies in the world. Its authority stems from its comprehensive and strict oversight of the entire drug lifecycle, from research and development to manufacturing and distribution, encompassing areas such as data integrity, quality assurance, and risk management systems.
• The five-day audit of Bloomage was conducted in accordance with ICH Q7 guidelines for active pharmaceutical ingredients (APIs) and covered six core systems: Quality, Facilities and Equipment, Materials, Production, Laboratory Control, and Packaging & Labeling. Additionally, the inspection included in-depth verification of computerized systems and electronic records.
• Achieving a ""zero-deficiency"" result under this level of scrutiny demonstrates Bloomage's precise operational control and its unwavering commitment to high-quality standards.

Bloomage Achieves Another Zero-Deficiency GMP Inspection

Notably, this is not the company's first ""zero-deficiency"" outcome from a national regulator in a major global market. In February 2025, Bloomage also passed an on-site GMP inspection by the Ministry of Food and Drug Safety (MFDS) of South Korea. That three-day inspection, conducted by two official auditors, concluded with the best possible result, confirming full compliance with no objectionable conditions (""zero-deficiency"").

Bloomage's regulatory strengths

To date, Bloomage's sodium hyaluronate API products have successfully passed five FDA inspections, one inspection by Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and two MFDS inspections in Korea. These achievements not only demonstrate the company's regulatory strengths, but also provide a solid compliance foundation for collaborations with partners around the world.

Sustained Quality, Global Trust: How Bloomage Scales with Precision and Compliance

• Bloomage has become a trusted global supplier by delivering world-class product quality and a consistent track record of regulatory approvals. Its sodium hyaluronate APIs have obtained 34 registrations and filings across the European Union, United States, Japan, Korea, Canada, Russia, India, etc. This includes 11 Certificates of Suitability (CEP) from the European Directorate for the Quality of Medicines (EDQM) and 10 Drug Master File (DMF) filing with the U.S. FDA — making Bloomage one of the most comprehensively registered sodium hyaluronate suppliers in the world.
• Bloomage has spent more than two decades providing high-quality, cutting-edge bioactive raw materials and tailored solutions to many of the world's leading companies in sectors ranging from beauty & care and pharma & aesthetics to nutrition & health.
• The company now operates a global marketing and supply network covering over 70 countries and regions, with subsidiaries established in the United States, France, Japan, Korea, and Singapore.

Bloomage continues to explore the potential of emerging markets by strengthening R&D and responding flexibly to evolving global demand. Its ability to allocate resources efficiently and tailor services to specific regional needs reflects its agility in navigating diverse market landscapes.

Certifications as a Strategic Foundation

• Sustainable brand strength is not built on marketing alone. An integrated infrastructure of quality systems, reliable supply chains, and the ability to adapt to increasingly complex global regulatory environments is required.
• For Bloomage, long-term investment in R&D and international certifications forms the foundation of its product excellence and market competitiveness. These efforts underpin the company's ability to deliver superior products and maintain a trustworthy brand image.
• Rather than viewing compliance as a cost, Bloomage sees it as a strategic moat. The company has built a full-chain system that integrates technical standards, quality control, and global regulatory alignment. This enables it to lead with substance, not slogans, and win trust in even the most competitive and tightly regulated markets.

About Bloomage

• Since its founding in 2000, Bloomage has grown into a leading international company specializing in the research, development, production, and sale of hyaluronic acid and other bioactive substances for the pharmaceutical, cosmetic and functional foods industries. 
• Bloomage's commitment to quality, innovation, and sustainable innovations have established the company as a trusted name for some of the world's most renowned brands. 
• It now serves more than 4,000 customers in over 70 countries.

Learn more at Bloomage.com