Drug factory · FDA FEI 3008205509
BCN Peptides Sa
POLIGONO INDUSTRIAL ELS VINYETS-FOGARS, CR. COMARCAL C-244 KM 22 SECTOR II, Sant Quinti De Mediona, Spain
Problems found, fixed voluntarily at FDA's last inspection, Oct 9, 2023.
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 2010: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Icatibant | Makes the active ingredient | Cipla USA., Inc. | 69097-664 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 9, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 15, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 16, 2015 | No problems found | Drug Quality Assurance | — |
| Apr 26, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 18, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.