FDA 483 - Nebraska Methodist Hospital - December 18, 2015

Nebraska Methodist Hospital received an FDA Form 483 following an inspection conducted from December 8 to December 18, 2015. The inspection identified significant deficiencies in the production of sterile drug products. Key observations included inadequate environmental monitoring, as viable and non-viable air, surface, and personnel sampling were not performed daily during sterile drug production. The hospital's procedures for preventing microbiological contamination were found lacking, specifically concerning the validation of sterilization processes. Smoke studies for laminar flow hoods were incomplete, failing to evaluate all primary hoods and the entire HEPA grid. Furthermore, the "worst-case scenario" for media fills had not been adequately established to ensure sterility of larger batches, with current media fill volumes being significantly smaller than typical production batches. Deficiencies were also noted in maintaining equipment within aseptic processing areas, specifically an un-evaluated occlusion in an ISO 5 laminar flow hood used for sterile drug production. Finally, laboratory controls were insufficient, as Certificates of Analysis for environmental surface sampling and personnel monitoring media were not reviewed prior to use. These observations, issued under the Federal Food, Drug and Cosmetic Act, indicate conditions requiring prompt corrective action to ensure the safety, quality, and purity of sterile drug products manufactured at the facility. The hospital is expected to address these deficiencies to comply with Good Manufacturing Practices.