FDA 483 - Bora Pharmaceuticals Inc. - August 30, 2022

An FDA inspection of Upsher Smith Laboratories, Inc. in Maple Grove, MN, identified significant deficiencies in equipment cleaning and maintenance. The firm's procedures for cleaning, quality unit review, and post-maintenance verification were found to be inadequate, leading to concerns about potential cross-contamination and compromised product integrity. These issues were observed in the pre-weigh room and on a blender, indicating a systemic problem with maintaining a clean state.