Drug factory · FDA FEI 3002807004
PolyPeptide Laboratories (Sweden) AB
Hogerudsgatan 21, Limhamn, Sweden
Problems found, fixed voluntarily at FDA's last inspection, Jan 23, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Desmopressin | Makes the active ingredient and tests it | Ferring Pharmaceuticals Inc. | 55566-2600, 55566-2700 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 23, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 10, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 27, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 20, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 7, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.