FDA 483 - Oregon Compounding Centers, Inc. - August 28, 2014

An FDA inspection of Oregon Compounding Centers, Inc. dba Creative Compounds, conducted from August 4 to August 28, 2014, revealed critical deficiencies in the firm's production of sterile drug products. The facility failed to establish and adhere to adequate procedures to prevent microbiological contamination, exhibiting poor aseptic techniques, improper material handling, and insufficient personnel gowning. Crucially, sterilization processes for aseptic filling, autoclave cycles for components, and filtration methods were not properly validated across all product types and batch sizes. The company also neglected to investigate drug products that failed sterility specifications and maintained an inadequate testing program, failing to conduct sterility and endotoxin testing on all batches, and performing insufficient potency testing. Furthermore, environmental monitoring, cleaning, and air handling systems in aseptic areas were found to be deficient. The firm also lacked a comprehensive stability program and supporting data for the assigned Beyond Use Dates of its sterile injectable products. Corrective actions are required to address these significant deviations from current Good Manufacturing Practices and ensure patient safety.