Next Science (ASX:NXS) has received a warning letter from the US Food and Drug Administration (FDA) following an inspection of its Jacksonville, Florida facility in August and September 2024, according to a Tuesday filing with the Australian bourse.
In its letter, the FDA determined that the company's Xperience, Blastx, and Surgx products did not have premarket approval related to certain marketing and labeling claims, the filing said.
The FDA also identified potential quality system violations during the inspection of the facility.
The company has implemented corrective actions and is working with the FDA to resolve the matters, while a follow-up inspection will be required to assess progress, the filing added.
Shares of the company fell past 8% at market close.
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