FDA 483 - Bora Pharmaceuticals Inc. - August 30, 2022
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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.
ID · 9793d6b9-7c22-49cc-a800-8486a8aabe45