Akorn Operating Company LLC
Overview
Akorn Pharmaceuticals is a specialty generic pharmaceutical company that develops, manufactures, and markets a collection of generic prescription drugs in various dosage forms. The company focuses on niche areas of the pharmaceutical market, providing solutions across multiple therapeutic categories.
Core services & business areas
Therapeutic areas
FDA compliance signals
14 FDA enforcement records linked to this company.
- 4832022-05-17
Written program not followed
- 4832022-05-17
Aseptic Processing Area
- 4832022-05-17
Investigations of discrepancies, failures
- 4832022-05-17
Procedures for sterile drug products
- 4832022-05-17
Written procedures followed
- 4832022-05-17
Scientifically sound laboratory controls
- 4832022-05-17
Extent of discrepancy, failure investigations
- 4832022-05-17
Contamination, chemical or physical change, deterioration
- 4832022-05-17
Computer control of master formula records
- 4832022-05-17
Following/documenting laboratory controls
- 4832022-05-17
Procedures not in writing, fully followed
- 4832022-05-17
Approve or reject components, products
- 4832022-05-17
Authority lacking to review records, investigate errors
- warning_letter2019-06-13
FDA Warning Letter (drug product)
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