FDA 483 - Advanced Instrumentations, Inc. - January 15, 2020

An FDA inspection of Advanced Instruments, Inc., a re-labeler and re-packager in Miami, FL, revealed significant deficiencies in their quality management system. Observations included inadequate corrective and preventive action procedures, incomplete complaint investigation records, and a lack of documentation for out-of-calibration equipment evaluations and remedial actions. These findings indicate a need for comprehensive improvements in their quality processes.