Advance ZincTek (ASX:ANO) has been notified of a US Food and Drug Administration (FDA) Import Alert, with the board indicating the action may be linked to broader tariff-related issues, according to a Friday Australian bourse filing.

The company noted that seven Australian manufacturers have received similar FDA alerts in the past 18 months, per the filing.

The company engaged US-based regulatory consultants, including former FDA officials, who will be on-site in Brisbane in the coming week to conduct a comprehensive review of its good manufacturing practice systems and address any regulatory concerns, the filing said.

The company is preparing a corrective action plan and expects to submit a formal petition to the FDA to lift the alert within four to eight weeks, with no material financial impact anticipated unless the alert persists beyond fiscal year 2026, the filing added.

The company's shares fell 3% in recent Friday trade.