Drug factory · FDA FEI 3007119522
Alexza Pharmaceuticals, Inc.
6550 Dumbarton Circle, Suite A, Fremont, CA, United States
No problems found at FDA's last inspection, Aug 1, 2025.
No Action Indicated: inspectors found no objectionable conditions.
9 drug inspections on record since 2010: 4 with no problems, 4 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Loxapine | Makes it and tests it | Alexza Pharmaceuticals, Inc. | 51097-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 1, 2025 | No problems found | Drug Quality Assurance | — |
| Dec 22, 2023 | No problems found | Bioresearch Monitoring | — |
| Sep 26, 2019 | No problems found | Drug Quality Assurance | — |
| May 21, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 13, 2014 | No problems found | Drug Quality Assurance | — |
| Jan 22, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 8, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 12, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 20, 2010 | Serious problems, FDA action | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 21, 2015 inspection
- Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy. - input/output verification 21 CFR 211.68(b)
Input to and output from the computer and records or data are not checked for accuracy. Electronic signatures based on are used, but they do not meet the id/password uniqueness requirements of 21 CFR Part 11.
Jan 22, 2014 inspection
- No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into the failure of a batch or any of its components to meet specifications. - input/output verification 21 CFR 211.68(b)
Input to and output from related systems of formulas are not checked for accuracy. Electronic records are used, but they do not meet systems validation requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Registered with FDA for: analysis; manufacture.