FDA Sends Form 483 to Sterile Manufacturer Akorn Pharmaceuticals’ Illinois Plant

The US Food and Drug Administration (FDA) on Tuesday released a Form 483 (which can be the precursor to a warning letter) with six observations to one of two Akorn Pharmaceuticals’ Decatur, Illinois-based sterile drug manufacturing facilities.

The observations were uncovered during a 10-day inspection in June and include quality control issues, unrecorded or unjustified deviations from written production and process control procedures, quality control responsibilities and procedures that are not followed, and the company’s failure to extend investigations into batch failures to other drug products that may have been associated with such a failure.

On the quality control front, FDA inspectors noted, “Specifically, there are no means of accounting for the total number of pages of forms used to document batch control and test results issued against the total number of pages used, discarded, or copied and the issuance of each control/test data form is not reconciled in Batch Records.”

In one of the examples on batch failures, FDA investigators also noted that foreign matter "was identified as a known process-related defect, yet no specific root cause for the particulate was identified. And the most likely root cause of failure to identify the critical/major defects during 100% visual inspection was identified as human error."

The Form 483 follows a warning letter for the site from 2007, which also detailed the site’s failure to establish separate or defined areas or other control systems as are necessary to prevent contamination or mix-ups during the course of aseptic processing. Akorn did not respond to a request for comment.

Form 483