Drug factory · FDA FEI 3014408462
Integrated Commercialization Solutions, LLC
6450 Lasalle Dr Ste B, Lockbourne, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, May 15, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2018: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aprepitant | Packages it | Heron Therapeutics, Inc. | 47426-401 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 15, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 13, 2018 | 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.
May 15, 2025 inspection
- Sampling/testing of labeling/packaging materials 21 CFR 211.122(a)
Labeling and packaging materials are not representatively sampled and examined upon receipt and before use in packaging and labeling of a drug product.
Registered with FDA for: label; pack; relabel; repack.