FDA 483 - Expert Chemical Analysis, Inc. - October 07, 2021

An FDA inspection of Expert Chemical Analysis, Inc. in San Diego, CA, a laboratory, revealed significant deficiencies across its quality system and laboratory operations. Observations included the absence of a quality control unit, inadequate investigations into out-of-specification results, and a failure to validate test methods. The firm also lacked proper documentation for equipment calibration and sufficient controls over analytical computer systems.