FDA 483 - Akorn, Inc. - September 17, 2010

This FDA Form 483 document details observations from an inspection concerning drug product production and control records. The primary issue identified is that the quality control unit did not review drug product production and control records to ensure compliance with established, approved written procedures before batch release or distribution.

Specifically, the firm's SOP QA 149, "Forms, Logs, and Logbooks-Preparation, Revision and Control," states that daily use logs or forms and maintenance logs are to be reviewed. However, several instances of unreviewed logs were observed:

* **Manual Inspection Booth Light Intensity Log forms:** 8 out of approximately 20 reviewed records were not regularly reviewed after completion. * **Packaging (b)(4) Equipment Set Up, Use and Cleaning Log:** Missing quality review from June 3, 2010, through July 23, 2010. * **Equipment Cleaning and Set-Up log for LABLR (b)(4) (b)(4) LABELER:** Not reviewed from August 7, 2008, through April 29, 2009; June 18, 2009, through August 18, 2009; and December 8, 2009, through September 7, 2010. * **Maintenance Log for LABLR (b)(4) LABELER:** Not reviewed