May 14, 2018 – Aerogen was recently inspected by the United States Food and Drug Administration (FDA). This inspection was a Quality System/ Current Good Manufacturing Practices (QS/ cGMP) inspection to determine if Aerogen devices are manufactured in accordance with the current QS Regulation of the United States. The FDA Investigator had no 483 findings from the Inspection.
John Power, Aerogen CEO said “A clean audit by FDA is a strong endorsement of our core intent to ensure our customers and patients will continue to receive the very best aerosol drug treatment available in the world. I am delighted to say we had a successful close out meeting following a 4 Day FDA Site Inspection of Aerogen. The conclusion of this Inspection is that Aerogen products meet the strict standards required for continued shipment to the United States.”