FDA 483 - Ropack, Inc. (Site A & B) - May 31, 2018

Ropack, Inc. in Anjou, Quebec, was cited with two observations during an FDA inspection from May 28-31, 2018, concerning significant deviations from good manufacturing practices. The inspection revealed failures in procedures designed to prevent objectionable microorganisms during drug product packaging, specifically an employee touching bottle interiors with unsanitized gloves. Additionally, the firm failed to follow written production and process control procedures, packaging multiple drug lots using non-validated parameters and equipment, and did not effectively implement or verify corrective actions.