Drug factory · FDA FEI 1000519239
Polypeptide Laboratories Inc
365 Maple Ave, Torrance, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, May 10, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 6 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Motixafortide | Tests it | BioLineRx USA Inc, Gamida Cell Inc. | 82737-073, 73441-062 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 10, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 19, 2021 | No problems found | Drug Quality Assurance | — |
| Jul 19, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 3, 2015 | No problems found | Drug Quality Assurance | — |
| Apr 12, 2013 | No problems found | Drug Quality Assurance | — |
| Feb 22, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 7, 2011 | No problems found | Drug Quality Assurance | — |
| Jan 13, 2010 | No problems found | Drug Quality Assurance | — |
| Mar 27, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.