Drug factory · FDA FEI 3004504760
Cosmo SpA
VIA CRISTOFORO COLOMBO 1, Lainate, Italy
Problems found, fixed voluntarily at FDA's last inspection, Nov 11, 2022.
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 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Budesonide | Makes it | Oceanside Pharmaceuticals., Santarus, Inc.. | 68682-309, 68012-309 |
| Clascoterone | Makes it | Caraco Pharmaceutical Laboratories, Ltd. | 47335-994 |
| Mesalamine | Makes it and tests it | Takeda Pharmaceuticals America, Inc. | 54092-100, 54092-476 |
| Remimazolam | Makes it and tests it | Acacia Pharma, Ltd. | 71390-011 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 11, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 2, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 8, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 18, 2013 | No problems found | Drug Quality Assurance | — |
| Nov 11, 2011 | 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.
Jul 8, 2015 inspection
- Adequate number of batches on stability 21 CFR 211.166(b)
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date. - 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; manufacture.