FDA EIR - DuPont Nutrition USA, Inc - December 15, 2021

An FDA inspection of Dupont Nutrition USA, Inc., located in Newark, DE, took place from November 17 to December 15, 2021. The inspection, conducted under Compliance Program 7356.002 for Drug Manufacturing Inspections, focused on the company's manufacturing of excipients for human drug products. The review identified several significant deficiencies, leading to the issuance of an 8-item Form FDA-483. The main observations included a failure to adequately assess the impact of process changes on validated procedures, and insufficient investigation of customer complaints and out-of-specification laboratory results. The firm's recall procedure was deemed inadequate, lacking clear criteria for initiating a recall. Furthermore, Dupont Nutrition USA failed to broaden discrepancy investigations to include all potentially affected product batches, neglected to incorporate critical in-process parameters in batch record reviews, and did not ensure all laboratory data was included in control records. The inspection also highlighted a lack of verification that analytical methods were suitable for their intended use. A separate discussion point noted ambiguous operational procedures. Management stated their commitment to providing a written response to all observations on the Form FDA-483, and planned to request an extension for their submission.