CDMO Kindeva Drug Delivery announced the completion of an FDA inspection at the company’s new laboratory facility in Woodbury, MN, USA and said that the site will continue with routine cGMP audits in the future. The company announced the opening of the Woodbury facility, home to a new analytical services business unit, in January 2024. According to Kindeva, the FDA has classified the inspection as “voluntary action indicated” (VAI) and has approved the lab as an alternate site for finished product testing of Proventil HFA MDI.
Kindeva VP of Analytical Services Jennifer Riter “We are delighted to have VAI status for the first time in our analytical services laboratory at our Woodbury site. 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.”
Read the Kindeva Drug Delivery press release.
