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.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。