Company
United StatesAlexza Pharmaceuticals, Inc., Fremont, CA – FDA Inspections
Inspection records and compliance data for Alexza Pharmaceuticals, Inc. in Fremont, California. 10 FDA inspections on record (1 OAI), last inspected December 19, 2025.
Company Profile
This profile covers Alexza Pharmaceuticals, Inc. based in Fremont, California, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 1
- VAI
- 3
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected August 20, 2010. Last inspected December 19, 2025.
Most cited issue areas
- input/output verification1 inspection
- No written record of investigation1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 19, 2025 | Not classified | Human Drugs | 1300206 |
| August 1, 2025 | Not classified | Human Drugs | 1281572 |
| December 22, 2023 | NAI | Human Drugs · Bioresearch Monitoring | 1227246 |
| September 26, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1109014 |
| May 21, 2015 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 926541 |
| February 13, 2014 | NAI | Human Drugs · Drug Quality Assurance | 866702 |
| January 22, 2014 | VAI | Human Drugs · Drug Quality Assurance | 863458 |
| November 8, 2012 | NAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 807836 |
| December 12, 2011 | VAI | Human Drugs · Drug Quality Assurance | 755936 |
| August 20, 2010 | OAI | Human Drugs · Drug Quality Assurance | 675646 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Alexza Pharmaceuticals, Inc.
FEI Number
3007119522
Address
6550 Dumbarton Cir Ste A, Fremont, California 94555, United States
Country
United States
ID: 4b71680e-1a0e-4237-8b2a-2e2c32c5c8fe