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.
About NeXtGen Biologics, Inc.
Headquartered in Alachua, FL, NeXtGen Biologics is a medical device company with a suite of patents covering an extracellular matrix (ECM) platform technology derived from the axolotl. Leveraging expertise in medical devices and breakthrough tissue technologies, the company is developing advanced solutions to address complex challenges in wound care, trauma, plastic surgery, cardiovascular disease, neurosurgery, orthopedics, and ophthalmology.
Contact:
Jonelle Toothman, 904-599-3264, jltoothman@nextgenbiologics.com
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