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# Multiple Violations Cited at Akorn
- URL: https://www.fdaweb.com/multiple-violations-cited-at-akorn/
- Published: 2019-07-09T12:00:00.000Z
- Updated: 2026-09-15T01:36:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144489

A 7/23-8/30/18 FDA inspection at the Akorn drug manufacturing facility in Somerset, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals that were similar to those found in inspections at other Akorn facilities. A just-released 6/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/akorn-inc-568173-06132019?ref=fdaweb.com) says the Somerset violations were: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production or control records, or other records and failing to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failing to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes; and
- failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.

The letter says Akorn’s quality systems are inadequate and do not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. FDA acknowledges the company is using a consultant to audit its operation and assist in meeting FDA requirements.

Akorn was told to submit results of a comprehensive investigation into the extent of inaccuracies in data records and reporting; a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and a management strategy for the firm that includes details of a global corrective and preventive action plan.

FDA also told the company to conduct a review of all quality assurance program audits and inspections within the last five years at all Akorn facilities and provide written certification that required corrective actions for such audits and inspections have been taken. If the review determines that actions have not been taken, the company is to provide a timetable for all related corrective actions identified in the audit.

Noting that similar violations were found in other Akorn facilities, FDA says “these repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate…. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products you manufacture conform to FDA requirements.”

Akorn was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.