AstraZeneca Pharmaceuticals LP
FDA inspection history across 2 sites, 2002 to 2023
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2002: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2002One warning letter, at Wilmington, Delaware.
- 2023One Form 483, at Mount Vernon, Indiana.
Cited most
Across all AstraZeneca Pharmaceuticals observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.194(a)(4)Laboratory records1
The complete AstraZeneca Pharmaceuticals file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Mount Vernon, Indiana
One Form 483 · 2023 · 2 observations
Latest: Form 483, Sep 19, 2023 →Wilmington, Delaware
One warning letter · 2002
Latest: Warning letter, Feb 22, 2002 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-19 | 483 Form 483 | Mount Vernon, Indiana | 2 | $99 |
| 2002-02-22 | Warning letter Warning letter | Wilmington, Delaware | — | $99 |
Investigators on these documents
FEI number 1825662 · most recent document Sep 19, 2023
About AstraZeneca Pharmaceuticals LP
How many FDA Form 483s has AstraZeneca Pharmaceuticals LP received?
FDA Intel has 1 Form 483 on file for AstraZeneca Pharmaceuticals LP; the most recent is dated Sep 19, 2023.
When was AstraZeneca Pharmaceuticals LP last inspected by FDA?
The most recent FDA inspection document on file for AstraZeneca Pharmaceuticals LP is a Form 483 dated Sep 19, 2023, for the site in Mount Vernon, Indiana.
What did FDA cite at AstraZeneca Pharmaceuticals LP?
The regulations cited most in the observations on file for AstraZeneca Pharmaceuticals LP are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.194(a)(4) (Laboratory records), 1 time.
Has AstraZeneca Pharmaceuticals LP received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for AstraZeneca Pharmaceuticals LP; the most recent is dated Feb 22, 2002.