FDA 483 - Pacira Pharmaceuticals, Inc. - April 19, 2023

The FDA conducted an inspection of Pacira Pharmaceuticals, Inc., a sterile manufacturer of human and animal drugs, from April 10 to April 19, 2023. The inspection revealed significant observations regarding the firm's quality system and equipment calibration records. A primary issue involved the failure to thoroughly review unexplained discrepancies and out-of-specification results, particularly concerning bupivacaine liposome injectable suspension. Investigations into quality events were found deficient, including a failure to fully implement recommended corrective and preventative actions for elevated particulate levels and a failure to identify root causes for multiple confirmed out-of-specification results in in vitro release testing for several product lots. Additionally, the inspection highlighted inadequate maintenance of equipment calibration records. Cleanroom certification records for a critical fill room showed individual measurements for HEPA filter airflow velocity and work height velocity that were outside established limits on multiple occasions. However, the firm reportedly only used average velocity readings, which were within limits, to assess pass/fail criteria for these parameters. These observations indicate that Pacira Pharmaceuticals must implement comprehensive corrective actions to address the deficiencies in its quality investigations and equipment monitoring practices to ensure compliance with regulatory standards for Good Manufacturing Practices.