Drugs

CGMP Violations at Akorn Decatur Plant

A 4/9-5/16/18 FDA inspection at the Akorn drug manufacturing facility in Decatur, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 1/4 Warning Letter says specific violations were:

failing to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failing to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas; and
failing to follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates.

The letter says the firm’s quality systems are inadequate and gives resources on establishing and following CGMP-compliant quality systems. It also says that because Akorn failed to correct repeat violations, it should engage a qualified consultant to assist it in meeting CGMP requirements.

FDA also expresses concerns about the accuracy of intervention, sanitization, and other records produced at the facility, and says the company’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs Akorn manufactures.

Akorn was told to provide (1) a comprehensive investigation into the extent of inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs; and (3) a management strategy for the company including details of its global corrective and preventive action plan.

The company also was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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