483
R&D Batteries IncFDA 483 - R&D Batteries Inc - August 06, 2025
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R&D Batteries, Inc., a medical device battery manufacturer in Burnsville, MN, was cited for two observations during an FDA inspection. The firm failed to ensure medical device labels bore a unique device identifier (UDI) with required production identifier segments. Additionally, the device history records lacked sufficient documentation of labels used for finished products.
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