Drug factory · FDA FEI 3007647000
Novo Nordisk Production Belgium SA
Font Saint Landry 10, Brussels, Belgium
Problems found, fixed voluntarily at FDA's last inspection, Apr 7, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2013: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bremelanotide | Makes it and labels it | Cosette Pharmaceuticals, Inc. | 0713-0897 |
| Epinephrine | Makes it and tests it | Adamis Pharmaceuticals Corporation | 38739-200 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 7, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 19, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 22, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 25, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 13, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 30, 2013 | Problems found, fixed voluntarily | 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.
Nov 25, 2016 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Registered with FDA for: analysis; label; manufacture; pack.