During the examination, FDA officials found that the company “failed to thoroughly investigate any unexplained discrepancy or failure of a batch”
US-based biopharmaceutical company Abraxis Bioscience has been issued with an official warning from the Food and Drug Administration (FDA), following an examination from 28 March to 6 April 2022.
This comes after the FDA identified multiple media fill failures occurring between April and October 2021, when the company simulated aseptic processing operations on the filling line used for its drug product Abraxane.
Writing to Abraxis, Director, Division of Pharmaceutical Quality Operations IV at FDA, Steven Porter said: “Multiple media fill failures occurred between April and October 2021, when simulating aseptic processing operations on the filling line used for your drug product Abraxane.”
Porter continued: “On November 15, 2021, you conducted a media fill using the (b)(4), as part of qualification of this new system. However, you did not address the extent of other equipment underneath the filling line worksurface that can pose a contamination risk due to insufficient disinfection.”
Although the FDA acknowledged Abraxis Bioscience took “significant steps” in response to the media fill failure, ultimately the company’s response was deemed “inadequate”.
When denouncing Abraxis’ unsatisfactory response to complaints, Porter cited: “Insufficient evaluation of the ruggedness of disposable systems…[while Abraxis] did not address the extent of other equipment underneath the filling line worksurface that can pose a contamination risk due to insufficient disinfection.”
Abraxis Bioscience is now urged to provide a list of responses, including a comprehensive risk assessment of all contamination hazards, a remediation plan, an independent review of equipment and a list of complaints received for the Abraxane drug product since January 2019.
Concluding, Porter said: “Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.”