Drug factory · FDA FEI 1000125456
Polypeptide Laboratories San Diego, LLC
9395 Cabot Drive, San Diego, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, May 15, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Motixafortide | Makes the active ingredient and tests it | BioLineRx USA Inc, Gamida Cell Inc. | 82737-073, 73441-062 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 15, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 16, 2019 | No problems found | Drug Quality Assurance | — |
| Oct 30, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 16, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 28, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 3, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.