Fresenius Kabi AG

Warning LetterOpen

Dr. Christian Hauer President of Transfusion Medicine and Cell Therapies, MedTech Division Fresenius Kabi AG Else-Kröner-Straße 1 61352 Bad Homburg GermanyFEI 3014215309Issued Sep 14, 2023Division of Biological Products Operations I

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Violations6

Issue DateSep 14, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Fresenius Kabi AG
Location: Dr. Christian Hauer President of Transfusion Medicine and Cell Therapies, MedTech Division Fresenius Kabi AG Else-Kröner-Straße 1 61352 Bad Homburg Germany
FEI Number: 3014215309
Country: Germany
Issue Date: September 14, 2023
Issuing Office: Division of Biological Products Operations I
Product Type: Drugs
Status: Open

Summary

Fresenius Kabi AG's Fenwal International facility was cited for significant current good manufacturing practice (CGMP) violations in the manufacture of blood-pack units and related component solutions including Alyx, Amicus, and InterSol platelet additive solution. The company failed to follow established written procedures and adequately investigate product discrepancies, with approximately 28 batches of terminally sterilized products exceeding the firm's bioburden action limits for bulk solutions during the January 2021 to February 2022 review period. These deviations violated Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act and Title 21 CFR Parts 210 and 211, and were documented during an FDA inspection conducted in September 2022.

Fresenius Kabi AG FDA Warning Letter, September 14, 2023