Abraxis BioScience, LLC
Form 483 issued April 6, 2022 · Phoenix, Arizona
- Inspection
- Mar 28 – Apr 6, 2022
- Investigators
- Lesley K. Satterwhite· Michael T. Cyrus
- Observations
- 2
- Pages
- 4
- FEI number
- 3006441852
In short: On April 6, 2022, FDA issued a Form 483 with 2 observations to Abraxis BioScience, LLC in Phoenix, Arizona (FEI 3006441852) after an inspection that ran Mar 28 – Apr 6, 2022. The investigators were Lesley K. Satterwhite and Michael T. Cyrus. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Lesley K. Satterwhite
6 documents · 2009–2022
Cites 110.80 (processes and controls) more than any other section. Most of their documents are for sites in Florida.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Abraxis BioScience, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Abraxis BioScience, LLC?
Lesley K. Satterwhite and Michael T. Cyrus are named on this Form 483, for the inspection of Mar 28 – Apr 6, 2022. Each investigator has a profile showing what they cite most.
When was Abraxis BioScience, LLC inspected by FDA?
The inspection ran Mar 28 – Apr 6, 2022, and the Form 483 is dated April 6, 2022.
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.