FDA 483 - Unilever Manufacturing (US), Inc. - March 10, 2020

An FDA inspection of Unilever Manufacturing (US), Inc. in Jonesboro, AR, revealed significant deficiencies in their quality system. Observations included a failure to adequately document conclusions and follow-up for investigations into out-of-specification batches and corrective and preventive actions (CAPAs). Additionally, the firm's quality control unit did not consistently follow its own procedures for deviation investigation and management, resulting in numerous open and unmonitored deviation reports.