Abraxis Bioscience LLC – FDA Warning Letter, Apr 6, 2022

The FDA inspected Abraxis Bioscience, LLC's drug manufacturing facility in Phoenix, AZ, from March 28 to April 6, 2022, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). This renders their drug product, Abraxane, adulterated under section 501(a)(2)(B) of the FD&C Act.

The primary violation cited was the firm's failure to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192) and effectively implement CAPA to control aseptic processing. Multiple media fill failures occurred between April and October 2021, simulating operations for Abraxane. Investigations into these failures were deemed inadequate, lacking rigor in determining root causes and scope of impact. Specific issues included: 1. **April 20, 2021, media fill:** High contamination (b)(4) units) with diverse microbes. Investigation attributed it to a damaged, contaminated valve, but failed to explain survival of vegetative microbes through sterilization or robust sterilization cycle design. 2. **July 12, 2021, media fill:** Multiple contaminated units. Root cause attributed to personnel gowning, poor RABS disinfection, and contaminated forceps. CAPA was insufficient, lacking holistic remediation of disinfection/decontamination programs. 3. **