Cardinal Health 414, LLC
Overview
Cardinal Health 414, LLC is a subsidiary of Cardinal Health, Inc., a global healthcare services and products company. The company focuses on providing pharmaceutical and medical products and services to various healthcare providers, enhancing healthcare efficiency and outcomes.
Therapeutic areas
API / Drug Master Files
Cardinal Health 414, LLC holds 3 active (8 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- ACTINIUM (225AC) NITRATE SOLUTIONActive2024-12-19
- GALLIUM GA-68 CHLORIDE SOLUTIONActive2024-04-18
- TETRAKIS (2-METHOXYISOBUTYLISONITRILE) COPPER (I) TETRAFLUOROBORATE DRUG SUBSTANCEActive2006-12-22
- SODIUM ACETATE C-11 INJECTIONInactive2011-01-19
- FLUOROMISONIDAZOLE F18 INJECTION([18F]FMISO)Inactive2009-06-16
- 3-DEOXY-3-[18F]FLUOROTHYMIDINE ([18F]FLT)Inactive2009-04-03
- SODIUM FLUORIDE F18 INJECTIONInactive2008-08-29
- FLUOROMISONIDAZOLE F 18 INJECTIONInactive2008-06-12
FDA compliance signals
50 FDA enforcement records linked to this company.
- 4832026-03-18
Orderly handling, prevention of mix-ups, prevention of contamination
- 4832026-02-06
Written QA procedures established, followed
- 4832026-02-06
Non-Conforming Product Investigation Incomplete
- 4832026-02-06
Complaint record contents
- 4832026-02-06
Correction of problems
- 4832025-09-12
Cleaning / Sanitizing / Maintenance
- 4832025-09-12
In-process samples representative, identified properly
- 4832025-09-12
Investigations of discrepancies, failures
- 4832025-08-28
Specifications and processes
- 4832025-07-31
Documentation of Non-Conforming Product Investigation
- 4832025-07-31
Correction of problems
- 4832025-07-31
Lack of disinfection, equipment/supplies from lower to higher quality air
- 4832025-07-31
Written QA procedures established, followed
- 4832025-07-31
Personnel, blocked or disrupted first air
- 4832025-07-01
Lab written procedures
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