Drugs

CGMP Violations at Akorn Decatur Facility

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 1/4 Warning Letter, announced by the company this week, 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; 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 responses to the inspection observations were inadequate. Because the company failed to correct repeat violations, FDA says, the agency strongly recommends engaging a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance and then assist in meeting the requirements, evaluating the completion and effectiveness of corrective and preventive actions.

The letter also expresses FDA concerns about the accuracy of intervention, sanitization, and other records produced at the facility. Akorn was told to provide (1) a comprehensive investigation into the extent of the inaccuracies in data, records, and reporting, including the results of data review for drugs distributed in the U.S.; (2) a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and a management strategy that includes details of Akorn’s global corrective and preventive actions plan.

Akorn was also 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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