FDA 483 - Arnold Tuber Industries, LLC - March 14, 2022

An FDA inspection of Arnold Tuber Industries, LLC, a medical device manufacturer in Orchard Park, NY, identified two significant observations. The firm was cited for inadequate procedures for corrective and preventive actions, specifically regarding verification and validation of their effectiveness. Additionally, the inspection found that a critical process for standard syringe caps lacked adequate validation, with issues in statistical rationale for sample and batch sizes.