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My DashboardInspection TrackerWarning LettersFagron BV

All Warning Letters

Fagron BV

Warning LetterOpen

Fascinatio Boulevard 350 3065 WB Rotterdam NetherlandsIssued May 12, 2026Center for Drug Evaluation and Research (CDER)

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

Violations7

Issue DateMay 12, 2026

Product TypeDrugs

StatusOpen

Letter Details

Firm: Fagron BV
Location: Fascinatio Boulevard 350 3065 WB Rotterdam Netherlands
FEI Number: N/A
Country: Netherlands
Issue Date: May 12, 2026
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Subject

Compounding Pharmacy/Adulterated Drug Products

Fagron BV FDA Warning Letter, May 12, 2026