Kindeva Drug Delivery, a drug-device combination product CDMO, has had its Woodbury, Minnesota facility inspected and successfully classified by the US Food and Drug Administration (FDA).
The analytical services business unit — launched earlier this year — can support integrated and stand-alone analytical services for the pharmaceutical, medical device and biopharmaceutical industries.
The analytical services site in Woodbury is now FDA registered and classified as Voluntary Action Indicated (VAI) with regards to cGMP.
Previously, a Prior Approval Supplement (PAS) was submitted to the board, which requested the approval of Woodbury as an alternate finished product test site for the inhalation aerosol, Proventil HFA.
PAS approval was given on June 20, 2024, and the Woodbury site will now be subject to cGMP surveillance audits from the FDA moving forward.
“We are delighted to have VAI status for the first time in our analytical services laboratory at our Woodbury site,” said Kindeva's Vice President of Analytical Services Jennifer Riter. “As a result of our FDA registration and our requested approval of Kindeva Drug Delivery L.P. located in Woodbury as an alternate finished product test site, this was a great opportunity for Kindeva to host the FDA for an inspection. The successful outcome demonstrates Kindeva’s laboratory as an established site to continue supporting our customers with analytical services as they bring their products to market.”
