FDA 483 - J-PAC LLC - November 09, 2023

An FDA inspection of J-PAC LLC DBA Life Science Outsourcing in Somersworth, NH, a medical device manufacturer, revealed two significant observations. The firm failed to adequately validate a critical packaging process and did not follow its own procedures for corrective and preventive actions, specifically regarding extension requests for CAPA due dates. These findings indicate deficiencies in the firm's quality system.