Dustin P Tran’s approach revolves around preventive contamination control measures, assurance of product quality, appropriate aseptic practices, and adherence to written procedures in all areas. He expects firms to provide scientific justification for their methods and outcomes, and pays close attention to their documentation practices.

FDA investigator Dustin P Tran has a keen focus on aseptic processes, potency testing methods, quality control and assurance, sterility and contamination control. He emphasizes the importance of protective apparel against contamination and carrying out required compendial methods. He also consistently notes the need for proper documentation, monitoring of environmental conditions in aseptic areas, and handling of consumer complaints and test result failures. His common targets involve infractions in container closure systems, distribution procedures, and stability data for assigning expiration date on products.