FDA 483 - Portland Compounding Pharmacy LLC - November 26, 2019

An FDA inspection conducted from November 13-26, 2019, at Lloyd Central Compounding Pharmacy in Portland, OR, identified significant issues in the production of sterile and non-sterile drugs. The inspection, documented in an FDA 483 report, highlighted three primary observations requiring corrective action. Firstly, the facility used non-sterile disinfecting agents and cleaning wipes within its ISO 5 classified aseptic processing areas, notably during the production of Hydromorphone HCL Intrathecal, posing a contamination risk. Secondly, the pharmacy produced hazardous drugs, including testosterone and estrogen products, without adequate cleaning protocols to prevent cross-contamination. Work surfaces and utensils were cleaned only with soap and water, lacking a necessary strong oxidizer for residue deactivation. Lastly, the inspection found that not all batches of sterile drug products, such as various intrathecal preparations, were laboratory tested for endotoxin prior to release, despite purporting to be pyrogen-free. The company, overseen by Director/Owner Natalie A. Gustafson, PharmD, is expected to address these observations to ensure compliance with drug quality and safety standards.