FDA 483 - Medical Products Laboratories, Inc. - July 21, 2015

An FDA inspection of Medical Products Laboratories, Inc. in Philadelphia, PA, revealed significant deficiencies in their manufacturing processes, laboratory controls, and material handling. Observations included unapproved production interventions, inadequate documentation of critical parameters, insufficient standard solution preparation for HPLC analysis, and improper control of rejected materials, with the latter being a repeat observation. These issues indicate a lack of adherence to established procedures and quality standards.