483
Arnold Tuber Industries, LLCArnold Tuber Industries, LLC – FDA 483, Feb 20, 2025
Record Details
An FDA inspection of Arnold Tuber Industries, LLC, a medical device manufacturer in Orchard Park, NY, revealed three significant observations. The firm was cited for inadequate validation of a manufacturing process, a lack of established procedures for design transfer, and an inadequately maintained device master record. These issues indicate deficiencies in the firm's quality system for medical device production.
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ID · c0b53304-364b-4a4e-b605-f169f29a5188
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