FDA 483 - Missouri Analytical Laboratories, Inc. - April 06, 2017

An FDA inspection of Missouri Analytical Laboratories, Inc., a pharmaceutical testing laboratory in Saint Louis, Missouri, revealed a significant issue regarding instrument calibration and qualification. The firm failed to qualify refrigerators and incubators used in its microbiology laboratory, where microorganisms, reagents, media, and product samples are stored and incubated. This indicates a lack of adherence to established written programs for equipment qualification.