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CLOSEOUT LETTER

Abraxis Bioscience LLC MARCS-CMS 633713 —

Reference #:
FEI 3006441852
Product:
Drugs

Recipient:
Recipient Name
Nathan Trembath
Recipient Title
General Manager
Abraxis Bioscience LLC

620 N 51 St. Ave.
Phoenix, AZ 85043
United States

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Secondary Issuing Offices

United States


Dear Mr. Trembath:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 633713 dated October 31, 2022.

Based on our evaluation, it appears that you have addressed the violation contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.

The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
Joan Johnson
Compliance Officer
Division of Drug Quality I

 
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