Drug factory · FDA FEI 3012101967
Cardinal Health 414, LLC
4343 W 62nd St, Indianapolis, IN, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 12, 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 2017: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Radium Ra-223 Cation | Makes it and tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-208 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 12, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 30, 2017 | 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.
Sep 12, 2025 inspection
- In-process samples representative, identified properly 21 CFR 211.160(b)(2)
Samples taken of in-process materials for determination of conformance to specifications are not representative. - 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. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; manufacture.