Company
United StatesAstraZeneca Pharmaceuticals, LP, Newark, DE – FDA Inspections
Inspection records and compliance data for AstraZeneca Pharmaceuticals, LP in Newark, Delaware. 8 FDA inspections on record, 2 Form 483s, last inspected June 26, 2026.
Company Profile
This profile covers AstraZeneca Pharmaceuticals, LP based in Newark, Delaware, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected September 10, 2009. Last inspected June 26, 2026.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance1 inspection
- Complaint Handling Procedure1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 26, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1327360 |
| April 26, 2024 | Not classified | Human Drugs | 1236034 |
| July 19, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1211584 |
| August 24, 2017 | NAI | Foods & Cosmetics, Human Drugs · Foodborne Biological Hazards | 1022686 |
| August 27, 2014 | VAI | Human Drugs · Drug Quality Assurance | 895233 |
| November 28, 2011 | NAI | Human Drugs · Drug Quality Assurance | 788561 |
| July 5, 2011 | VAI | Human Drugs · Drug Quality Assurance | 737328 |
| September 10, 2009 | NAI | Human Drugs · Drug Quality Assurance | 611523 |
FDA documents
Form 483s (1)
EIRs (1)
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Company Information
Name
AstraZeneca Pharmaceuticals, LP
FEI Number
2517100
Address
587 Old Baltimore Pike, Newark, Delaware 19702, United States
Country
United States
ID: ebec0358-60f4-4d3d-88a0-f03f946518ea