Abraxis BioScience, LLC
Form 483 issued August 17, 2018 · Phoenix, Arizona
- Inspection
- Aug 13 – Aug 17, 2018
- Investigators
- Jamie L. Dion· Zachary L. Stamm
- Observations
- 2
- Pages
- 3
- FEI number
- 3006441852
In short: On August 17, 2018, FDA issued a Form 483 with 2 observations to Abraxis BioScience, LLC in Phoenix, Arizona (FEI 3006441852) after an inspection that ran Aug 13 – Aug 17, 2018. The investigators were Jamie L. Dion and Zachary L. Stamm. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.63 (1×) · 211.160(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Established laboratory control mechanisms are not followed and documented at…
This inspection in context
Jamie L. Dion
11 documents · 2013–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
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 211.63
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 facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Abraxis BioScience, LLC?
Jamie L. Dion and Zachary L. Stamm are named on this Form 483, for the inspection of Aug 13 – Aug 17, 2018. Each investigator has a profile showing what they cite most.
When was Abraxis BioScience, LLC inspected by FDA?
The inspection ran Aug 13 – Aug 17, 2018, and the Form 483 is dated August 17, 2018.
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.