Company
United StatesAstraZeneca Pharmaceuticals LP, Mount Vernon, IN – FDA Inspections
Inspection records and compliance data for AstraZeneca Pharmaceuticals LP in Mount Vernon, Indiana. 8 FDA inspections on record, 1 Form 483, last inspected September 19, 2023.
Company Profile
This profile covers AstraZeneca Pharmaceuticals LP based in Mount Vernon, Indiana, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 3
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected January 29, 2009. Last inspected September 19, 2023.
Most cited issue areas
- Written in-process control procedures2 inspections
- Absence of Written Procedures1 inspection
- Complete Test Data1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1218331 |
| January 28, 2016 | NAI | Human Drugs · Drug Quality Assurance | 965123 |
| October 25, 2013 | VAI | Human Drugs · Drug Quality Assurance | 853863 |
| September 13, 2012 | NAI | Human Drugs · Drug Quality Assurance | 798609 |
| October 28, 2011 | VAI | Human Drugs · Drug Quality Assurance | 751470 |
| August 12, 2011 | NAI | Human Drugs · Drug Quality Assurance | 741276 |
| February 3, 2010 | NAI | Human Drugs · Drug Quality Assurance | 664877 |
| January 29, 2009 | NAI | Human Drugs · Drug Quality Assurance | 566232 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
AstraZeneca Pharmaceuticals LP
FEI Number
1825662
Address
4601 Highway 62 E, Mount Vernon, Indiana 47620, United States
Country
United States
ID: 80a406f0-7f62-4d81-841e-7f01c9950c06