FDA 483 - Banner Pharmacy Services, LLC - October 08, 2019

An FDA inspection of Banner Pharmacy Services, LLC, a producer of sterile drug products in Chandler, AZ, was conducted from October 2 to October 8, 2019. This inspection led to the issuance of an FDA Form 483, detailing observations related to the firm's adherence to regulatory standards for sterile drug manufacturing. The primary issue identified was that disinfecting agents used within the critical ISO 5 classified aseptic processing areas were not sterile. Specifically, a review of the company's Standard Operating Procedure (SOP) 02-04.02, "Cleaning and Disinfecting of the Sterile Compounding Area," referenced specific cleaning agents. However, during the inspection, it was confirmed that one of these agents, though redacted in the document, was not sterile. This directly contradicts the necessary conditions for maintaining sterility in environments where sterile drug products are compounded. The FDA Form 483 documents these inspectional observations and is not a final determination of compliance. Banner Pharmacy Services, LLC is required to address these findings, presenting either objections or detailing corrective actions already implemented or planned, to ensure the sterility and quality of their products and align with Good Manufacturing Practices, demonstrating their commitment to regulatory adherence and patient safety.