FDA 483 - Kindeva Drug Delivery L.P. - April 03, 2024

Kindeva Drug Delivery LP in Woodbury, MN, a contract testing laboratory, was cited for significant deficiencies during an FDA inspection. The observations include a lack of scientifically sound laboratory test procedures, inadequate written procedures for the quality control unit, and a failure to maintain backup files for electronic raw data. These issues primarily impact the testing and data integrity for albuterol sulfate MDI.