FDA Intel

Abraxis BioScience, LLC

Form 483 issued October 6, 2023 · Phoenix, Arizona

Inspection
Sep 25 – Oct 6, 2023
Investigators
Carrie A. Hughes· Nicholas L. Hunt
Observations
6
Pages
4
FEI number
3006441852

In short: On October 6, 2023, FDA issued a Form 483 with 6 observations to Abraxis BioScience, LLC in Phoenix, Arizona (FEI 3006441852) after an inspection that ran Sep 25 – Oct 6, 2023. The investigators were Carrie A. Hughes and Nicholas L. Hunt. Most observations concern facilities & equipment and quality system.

At a glance

Facilities & equipment and quality system account for 4 of 6 observations.

Facilities & equipment2
Quality system2
Laboratory controls2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.68(b)

    Input to and output from the computer, related systems of formulas and records or data are…

  2. 02
    21 CFR 211.192

    Written records of investigations into unexplained discrepancies do not always include…

  3. 03
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit are not in…

  4. 04
    21 CFR 211.42(c)(10)(vi)

    Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…

2 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Carrie A. Hughes

8 documents · 2017–2023

Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.

The firm

Abraxis BioScience, LLC history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.68(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Abraxis BioScience, LLC?

FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.

Who inspected Abraxis BioScience, LLC?

Carrie A. Hughes and Nicholas L. Hunt are named on this Form 483, for the inspection of Sep 25 – Oct 6, 2023. Each investigator has a profile showing what they cite most.

When was Abraxis BioScience, LLC inspected by FDA?

The inspection ran Sep 25 – Oct 6, 2023, and the Form 483 is dated October 6, 2023.

How do I get the full Form 483 for Abraxis BioScience, LLC?

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