Drug factory · FDA FEI 3006272083
Eurofins Biopharma Product Testing, Denmark A/S
Oernebjergvej 1, Glostrup, Denmark
No problems found at FDA's last inspection, May 17, 2023.
No Action Indicated: inspectors found no objectionable conditions.
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 | Tests it | Eton Pharmaceuticals, Inc. | 71863-123 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 17, 2023 | No problems found | Drug Quality Assurance | — |
| Jun 22, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Dec 14, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 30, 2012 | No problems found | Drug Quality Assurance | — |
| May 12, 2009 | 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.
Jun 22, 2016 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures and laboratory mechanisms are not recorded and justified. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - 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.