Company
United StatesAstraZeneca Pharmaceuticals LP, Gaithersburg, MD – FDA Inspections
Inspection records and compliance data for AstraZeneca Pharmaceuticals LP in Gaithersburg, Maryland. 16 FDA inspections on record, 1 Form 483, last inspected January 14, 2026.
Company Profile
This profile covers AstraZeneca Pharmaceuticals LP based in Gaithersburg, Maryland, United States.
FDA Inspection History
- FDA inspections
- 16
- OAI
- 0
- VAI
- 3
- NAI
- 10
- Unclassified
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 20, 2013. Last inspected January 14, 2026.
Most cited issue areas
- Late submission of 15-day report2 inspections
- Complaint Handling Procedure1 inspection
- Complete Test Data1 inspection
FDA inspections (16)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 14, 2026 | Not classified | Human Drugs | 1299436 |
| October 25, 2024 | Not classified | Human Drugs | 1254239 |
| May 31, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1238346 |
| January 22, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1230136 |
| July 18, 2023 | NAI | Human Drugs · Bioresearch Monitoring | 1211604 |
| September 30, 2021 | NAI | Human Drugs · Bioresearch Monitoring | 1157291 |
| February 26, 2021 | NAI | Human Drugs · Bioresearch Monitoring | 1136278 |
| October 27, 2020 | NAI | Human Drugs · Bioresearch Monitoring | 1132938 |
| October 11, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1072798 |
| February 5, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1040293 |
| January 30, 2018 | VAI | Human Drugs · Postmarket Surv. and Epidemiology | 1039113 |
| September 20, 2017 | Not classified | Human Drugs | 1029381 |
| May 18, 2017 | NAI | Human Drugs · Bioresearch Monitoring | 1012904 |
| December 9, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 999491 |
| September 29, 2015 | NAI | Human Drugs · Bioresearch Monitoring | 946858 |
| March 20, 2013 | VAI | Human Drugs · Bioresearch Monitoring | 823366 |
FDA documents
Form 483s (1)
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Company Information
Name
AstraZeneca Pharmaceuticals LP
FEI Number
1000198729
Address
1 Medimmune Way, Gaithersburg, Maryland 20878, United States
Country
United States
ID: f2e34b74-3ef4-4f39-8f6f-41eceb3bb779