Drug factory · FDA FEI 3004477049
GBA Pharma GmbH
Anna-Sigmund-Strasse 7, Neuried, Germany
No problems found at FDA's last inspection, Dec 11, 2024.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2009: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Triheptanoin | Tests it | Ultragenyx Pharmaceutical Inc. | 69794-050 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 11, 2024 | No problems found | Drug Quality Assurance | — |
| Oct 12, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 18, 2013 | No problems found | Drug Quality Assurance | — |
| Jul 14, 2009 | No problems found | 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.
Oct 12, 2018 inspection
- Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis.