FDA 483 - KVK Tech, Inc. - June 11, 2021

KVK-Tech, Inc. was inspected and found to have significant deficiencies across multiple areas of its drug product manufacturing operations. Key issues include inadequate equipment cleaning procedures and validation, insufficient investigations into product complaints and deviations, and a lack of proper quality unit oversight. The firm also demonstrated poor data integrity controls, inadequate employee training, and facility issues such as recurring roof leaks and insufficient space for equipment segregation.