GLOBE NEWSWIRE: NeXtGen Biologics Successfully Completes First FDA Audit with Zero 483 Observations

GAINESVILLE, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- NeXtGen Biologics announced today the successful completion of a two-day inspection by the U.S. Food and Drug Administration (FDA). The inspection concluded with no Form 483 observations issued, underscoring the company’s commitment to quality, compliance, and operational excellence.

“Our vision has always been to pair scientific innovation with uncompromising integrity,” said Jonelle Toothman, co-founder and CEO of NeXtGen Biologics. “Completing this inspection with no observations highlights both the rigor of our quality systems and the high standards our team holds in every aspect of their work.”

A form 483 observation is issued when FDA inspectors identify conditions that may violate the Food, Drug, and Cosmetic Act. Concluding an inspection without observations is an important validation of a company’s quality and compliance practices.

This successful inspection represents a key step as NeXtGen Biologics advances its ECM platform technology. The company is continuing research and development to support future applications in wound care, surgery, and other medical disciplines.