Kindeva’s Woodbury Facility Receives FDA VAI Status

• Kindeva Drug Delivery’s Woodbury facility receives FDA classification as Voluntary Action Indicated (VAI).

• The site will support integrated and stand-alone analytical services for various sectors.

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

The Woodbury site received Voluntary Action Indicated (VAI) status regarding cGMP. A Prior Approval Supplement (PAS) was submitted on February 29, 2024, requesting approval of Kindeva Drug Delivery L.P. in Woodbury as an alternate finished product test site for Proventil HFA (albuterol sulfate) Inhalation Aerosol. The FDA inspected the site from April 1-3, 2024, and the PAS was approved on June 20, 2024. Moving forward, the Woodbury site will be subject to routine cGMP surveillance audits.

“We are delighted to have VAI status for the first time in our analytical services laboratory at our Woodbury site,” said Jennifer Riter, Vice President of Analytical Services at Kindeva. “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.”