Following inspection by the FDA or audit by your Notified Body or another regulatory agency you may have been left with issues, such as a Form FDA 483 that need to be resolved - this is more common place than at any time previously in the industry as inspection numbers and frequency rise. Failure to take timely and appropriate action may result in further and more severe actions by the Agency, which can include product and/or component import restrictions, product licence restrictions or removals, further agency inspection, fines, and in some cases imprisonment of executives. All of this incurs cost to your business, threat of further consumer litigation, negative publicity, loss of contracts etc. Auxilium has the experience to help your business to respond in a timely and satisfactory manner through remediation activities to bring closure to findings and help prevent further more complex issues developing.