FDA 483 - LICO Industries, LLC - July 08, 2021

LICO Industries, LLC, a repacker in Mohave Valley, AZ, was inspected and cited for four observations. The inspection revealed deficiencies in documenting the release of bulk drugs, inadequate calibration procedures for equipment, improper temperature control for drug storage, and a lack of documented examination of reserve samples. These issues indicate a failure to maintain proper quality control and assurance for drug products.