Bloomage Achieves FDA GMP Audit with Perfect Compliance, Strengthening Global Trust

Bloomage Achieves FDA GMP Audit with Zero Deficiencies



Bloomage, a prominent innovator in hyaluronic acid and bioactive substances, has recently announced a remarkable achievement in its commitment to quality. The company successfully passed the U.S. Food and Drug Administration (FDA)'s Good Manufacturing Practice (GMP) audit with a coveted result of "No Action Indicated" (NAI), which signifies complete compliance with no objectionable findings. This outcome is the epitome of quality assurance in the pharmaceutical industry, providing clients and partners with a reaffirmation of Bloomage's robust quality management system.

The FDA's comprehensive five-day audit meticulously covered six essential systems, including Quality, Facilities and Equipment, Materials, Production, Laboratory Control, and Packaging & Labeling. Notably, the audit adhered to the guidelines established by the International Council for Harmonisation (ICH) for active pharmaceutical ingredients (APIs). The thorough examination included rigorous verification of computerized systems and electronic record management practices, which highlights Bloomage's commitment to transparency and operational precision in its manufacturing processes.

Bloomage's impressive record in maintaining quality standards isn’t merely a one-off occurrence; this marks another instance of the company's unwavering dedication. Earlier this year, Bloomage also achieved a

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