Kindeva Drug Delivery’s Woodbury, MN facility, which was launched earlier this year, has been inspected and successfully classified by the FDA. The new business unit supports both integrated and stand-alone analytical services for the pharmaceutical, biopharmaceutical, and medical device sectors.

Kindeva’s analytical services site in Woodbury is now FDA registered and classified as Voluntary Action Indicated (VAI) with regards to cGMP. A Prior Approval Supplement (PAS) was submitted February 29, 2024, requesting approval of Kindeva Drug Delivery L.P. located in Woodbury as an alternate finished product test site for Proventil HFA (albuterol sulfate) Inhalation Aerosol. The FDA inspected Woodbury April 1-3, 2024, and the PAS was approved June 20, 2024. The Woodbury site is now on the list for routine cGMP surveillance audits moving forward.

“We are delighted to have VAI status for the first time in our analytical services laboratory at our Woodbury site,” said Kindeva 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.”