FDA 483 - Instrumed International Inc - December 05, 2023

Instrumed International Inc, a contract manufacturer/repackager/relabeller in Schaumburg, IL, was inspected by the FDA, revealing significant deficiencies in their quality system. The inspection cited inadequate procedures for ensuring purchased product conformity, establishing and closing corrective and preventive actions, and documenting CAPA activities. Additionally, the firm lacked proper documentation availability and failed to establish adequate procedures for reworking nonconforming products.