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Fresenius Kabi USA LLC Warning Letter Details

Warning Letter

Fresenius Kabi USA LLC

61346 Bad Homburg Germany, (b)(4)

Issue DateSeptember 22, 2026

FEI Number1450022

Violations4

CountryGermany

Issuing Office

Center for Drug Evaluation and Research (CDER)

Product Type

Drugs

Status

Open

Subject

CGMP/Finished Pharmaceuticals/Adulterated

Fresenius Kabi USA LLC FDA Warning Letter, September 22, 2026