The agency did not inspect Cook’s plant in Bloomington, Indiana – which houses capacity to fill 15 million vials and 70 million syringes a year – and instead based its decision on a previous review of the same production line.
Cook spokesman Brian Lange told Outsourcing-pharma.com that: “The approval was sought after by our client, as they were looking to secure the commercial supply for the market.
He added that: “The product helps fill a void that was left by another injectable that has been on the drug shortage list. So patients who have not had access to the treatment they need will now have a secure supply of available product moving forward,” but declined to name the product for reasons of client confidentiality.
The 900,000 square foot Bloomington plant provides customers with process development services as well as cell culture manufacturing. Cook also undertakes vial filling, formulation development and analytical services at the site.
According to Lange the pre-approval inspection waiver was based established Food and Drug Administration (FDA) risk assessment procedures and is not the first that the contract manufacturing organisation has received.
“The waived inspection was a decision of the Agency based upon Cook Pharmica’s recent prior inspection results of the same production fill line. The FDA utilizes risk assessment to prioritize facilities and manage resource allocation for inspections.
“Cook has had previous experience with occasional waived pre-approval inspections when it owned and operated Cook Pharmaceutical Solutions.”