FDA 483 - Pretika Corporation - October 25, 2019

Pretika Corporation, a repackager/relabeler in Laguna Niguel, CA, received a Form FDA 483 with seven observations during an inspection from October 22-25, 2019. The inspection revealed a significant lack of established procedures across multiple critical quality system areas. This indicates a fundamental absence of a robust quality management system, impacting complaint handling, corrective and preventive actions, medical device reporting, purchasing controls, document control, labeling, and device history records.