Abraxis BioScience, LLC
FDA inspection history in Phoenix, Arizona, 2018 to 2023
- 4
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2018: one Form 483; 2020: one Form 483; 2022: one warning letter and one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–23Four Form 483s and one warning letter, at Phoenix, Arizona.
- 2023The longest 483 on file: 6 observations over 4 pages at Phoenix, Arizona.
Cited most
Across all Abraxis BioScience observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.100(b)Written procedures; deviations2
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160(a)General requirements1
The complete Abraxis BioScience file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Phoenix, Arizona
Four Form 483s, one warning letter and one close-out letter · 2018 to 2023 · 14 observations
Latest: Form 483, Oct 6, 2023 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-06 | 483 Form 483 | Phoenix, Arizona | 6 | $99 |
| 2022-10-31 | Warning letter Warning letter | Phoenix, Arizona | — | $99 |
| 2022-04-06 | 483 Form 483 | Phoenix, Arizona | 2 | $99 |
| 2020-02-19 | 483 Form 483 | Phoenix, Arizona | 4 | $99 |
| 2018-08-17 | 483 Form 483 | Phoenix, Arizona | 2 | $99 |
| Undated | Close-out Close-out letter | Phoenix, Arizona | — | $99 |
Investigators on these documents
Carrie A. Hughes (2)Jamie L. Dion (1)Lesley K. Satterwhite (1)Michael T. Cyrus (1)Nicholas L. Hunt (1)Zachary L. Stamm (1)
FEI number 3006441852 · most recent document Oct 6, 2023
About Abraxis BioScience, LLC
How many FDA Form 483s has Abraxis BioScience, LLC received?
FDA Intel has 4 Form 483s on file for Abraxis BioScience, LLC; the most recent is dated Oct 6, 2023.
When was Abraxis BioScience, LLC last inspected by FDA?
The most recent FDA inspection document on file for Abraxis BioScience, LLC is a Form 483 dated Oct 6, 2023, for the site in Phoenix, Arizona.
What did FDA cite at Abraxis BioScience, LLC?
The regulations cited most in the observations on file for Abraxis BioScience, LLC are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.100(b) (Written procedures; deviations), 2 times; 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 2 times.
Has Abraxis BioScience, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Abraxis BioScience, LLC; the most recent is dated Oct 31, 2022.