FDA 483 - Medical Products Laboratories, Inc. - October 12, 2017

Medical Products Laboratories, Inc. in Philadelphia, PA, was inspected by the FDA, resulting in eight observations related to laboratory controls and record-keeping. Key issues included inadequate calibration of instruments, incomplete laboratory records, deficiencies in establishing scientifically sound test procedures, and insufficient employee training. These findings indicate significant concerns regarding the firm's quality control and assurance practices for pharmaceutical and medical device products.