FDA 483 - Medical Products Laboratories, Inc. - July 13, 2023

An FDA inspection of Medical Products Laboratories, Inc. in Philadelphia, PA, from June 28 to July 13, 2023, revealed a significant equipment qualification deficiency. The firm failed to qualify its aerosol manufacturing line after modifications, yet continued to use it for packaging commercial drug products. This indicates a serious lapse in ensuring equipment is fit for its intended use in drug manufacturing.