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My DashboardInspection TrackerWarning LettersEstar Technologies Ltd

All Warning Letters

Estar Technologies Ltd

Warning LetterOpen

Recipient Title Chief Executive Officer and Founder, 15, Ha-Merkava Holon 5885111 IsraelIssued Apr 22, 2026Center for Biologics Evaluation and Research

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations3

Issue DateApr 22, 2026

Product TypeBiologics

StatusOpen

Letter Details

Firm: Estar Technologies Ltd
Location: Recipient Title Chief Executive Officer and Founder, 15, Ha-Merkava Holon 5885111 Israel
FEI Number: N/A
Country: Israel
Issue Date: April 22, 2026
Issuing Office: Center for Biologics Evaluation and Research
Product Type: Biologics
Status: Open

Subject

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

Estar Technologies Ltd FDA Warning Letter, April 22, 2026