Drug factory · FDA FEI 3002478693
Integrated Commercialization Solutions, LLC
420 International Blvd, Suite 500, Brooks, KY, United States
No problems found at FDA's last inspection, Aug 8, 2025.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2010: 6 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Allogenic Bone-Marrow-Derived Mesenchymal Stem Cells and Isopropyl Alcohol | Packages it | Mesoblast | 73648-111, 73648-112, 73648-113 +9 |
| Triheptanoin | Packages it | Ultragenyx Pharmaceutical Inc. | 69794-050 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 8, 2025 | No problems found | Drug Quality Assurance | — |
| Jul 15, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 12, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 28, 2012 | No problems found | Drug Quality Assurance | — |
| Jan 3, 2011 | Serious problems, FDA action | Drug Quality Assurance | — |
| Oct 7, 2010 | No problems found | Drug Quality Assurance | — |
| Jun 24, 2010 | No problems found | Drug Quality Assurance | — |
| Feb 5, 2010 | 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 15, 2019 inspection
- 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: label; pack; relabel; repack.