Abraxis BioScience, LLC
Form 483 issued February 19, 2020 · Phoenix, Arizona
- Inspection
- Feb 10 – Feb 19, 2020
- Investigator
- Carrie A. Hughes
- Observations
- 4
- Pages
- 5
- FEI number
- 3006441852
In short: On February 19, 2020, FDA issued a Form 483 with 4 observations to Abraxis BioScience, LLC in Phoenix, Arizona (FEI 3006441852) after an inspection that ran Feb 10 – Feb 19, 2020. The investigator was Carrie A. Hughes. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.100(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Written records of investigations into unexplained discrepancies do not always include…
- 04
Deviations from written production and process control…
This inspection in context
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 firmAbraxis BioScience, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Abraxis BioScience, LLC?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Abraxis BioScience, LLC?
Carrie A. Hughes is named on this Form 483, for the inspection of Feb 10 – Feb 19, 2020. Each investigator has a profile showing what they cite most.
When was Abraxis BioScience, LLC inspected by FDA?
The inspection ran Feb 10 – Feb 19, 2020, and the Form 483 is dated February 19, 2020.
How do I get the full Form 483 for Abraxis BioScience, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.