Abraxis Bioscience LLC

Warning LetterClosed

Mr. Giovanni Caforio Chief Executive Officer Abraxis Bioscience LLC 620 N 51st Ave. Phoenix , AZ 85043 United States Giovanni.Caforio@bms.comFEI 3006441852Issued Oct 31, 2022Center for Drug Evaluation and Research | CDER

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Violations2

Issue DateOct 31, 2022

Product TypeDrugs

StatusClosed

Closeout LetterMar 25, 2024

Letter Details

Firm: Abraxis Bioscience LLC
Location: Mr. Giovanni Caforio Chief Executive Officer Abraxis Bioscience LLC 620 N 51st Ave. Phoenix , AZ 85043 United States Giovanni.Caforio@bms.com
FEI Number: 3006441852
Country: United States
Issue Date: October 31, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Closed
Closeout Letter: March 25, 2024

Summary

Abraxis Bioscience LLC's Phoenix drug manufacturing facility violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering its products adulterated. During an FDA inspection in March-April 2022, investigators identified critical failures in investigating batch discrepancies and implementing corrective actions following multiple media fill failures in aseptic processing operations for Abraxane between April and October 2021. The company inadequately assessed root causes of the processing failures and subsequently released potentially affected batches in December 2021 after only one successful media fill run in November 2021, demonstrating insufficient remediation to restore the manufacturing line to a state of control.

Abraxis Bioscience LLC FDA Warning Letter, October 31, 2022