FDA 483 - Akorn, Inc. - November 10, 2009

During an FDA inspection from October 19 to November 10, 2009, two observations were made regarding the firm's handling of drug product complaints.

Observation 1 details deficiencies in procedures for handling written and oral complaints. The "Complaint Receipt, RA120" procedure (effective 12-22-08) lacks specific instructions for receiving and documenting MedWatch forms from regulatory agencies. The "Processing and Investigation of Complaints, SOP RA 110" procedure (effective 10-19-09) is deficient as it does not specify when the final Quality Assurance (QA) review is required. Several complaints (900170412, 900279210, 900206012) had final QA reviews completed beyond the 90-calendar-day timeframe. Additionally, SOP RA 110 lacks instructions for handling complaint investigations from contract customers that extend beyond 90 calendar days, with multiple such investigations (900548210, 900648210, 900148610, 900248610) remaining open past 90 days. Furthermore, the "Adverse Drug Experience Decision Tree, form # ra0006" was not reviewed by QA for several complaints (8001