FDA 483 - PROSPECT LIFE SCIENCES - November 17, 2022

An FDA inspection of PROSPECT LIFE SCIENCES, a medical device contract manufacturer in Westminster, CO, revealed two significant observations. The firm was cited for inadequate documentation of corrective and preventive action (CAPA) activities, specifically regarding root cause investigations and verification of effectiveness. Additionally, the inspection found deficiencies in the company's procedures for receiving, reviewing, and evaluating product complaints, including a lack of requirements to review relevant quality data sources during investigations.