483
Arnold Tuber Industries, LLCArnold Tuber Industries, LLC – FDA 483, Mar 14, 2022
Record Details
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.
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ID · f55e7bd8-68d1-4d83-b073-a611b88c3353
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