Drug factory · FDA FEI 3005724652
Ferring International Center SA
Chemin de la Vergognausaz 50, St-Prex, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Feb 6, 2026.
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 2012: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Desmopressin | Makes it, tests it and packages it | Ferring Pharmaceuticals Inc., Nordic Pharma, Inc. | 55566-2600, 55566-2700, 69918-101 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 6, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 29, 2023 | No problems found | Drug Quality Assurance | — |
| Aug 23, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 13, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Feb 7, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 15, 2012 | 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.
Aug 23, 2019 inspection
- 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 conform to appropriate standards of identity, strength, quality and purity. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - 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.
Jan 13, 2017 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. - Valid stability test methods 21 CFR 211.166(a)(3)
The written stability program for drug products does not include reliable, meaningful and specific test methods. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - 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.
Registered with FDA for: analysis; label; manufacture; pack.