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.
Therapeutic areas
FDA compliance signals
14 FDA enforcement records linked to this company.
- 4832022-05-17
Computer control of master formula records
- 4832022-05-17
Procedures not in writing, fully followed
- 4832022-05-17
Following/documenting laboratory controls
- 4832022-05-17
Investigations of discrepancies, failures
- 4832022-05-17
Approve or reject components, products
- 4832022-05-17
Extent of discrepancy, failure investigations
- 4832022-05-17
Authority lacking to review records, investigate errors
- 4832022-05-17
Written program not followed
- 4832022-05-17
Aseptic Processing Area
- 4832022-05-17
Procedures for sterile drug products
- 4832022-05-17
Scientifically sound laboratory controls
- 4832022-05-17
Written procedures followed
- 4832022-05-17
Contamination, chemical or physical change, deterioration
- warning_letter2019-06-13
FDA Warning Letter (drug product)
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