483
Surface Guard Films LLCFDA 483 - Surface Guard Films LLC - June 03, 2026
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Record Details
An FDA inspection of Pregis Protective Films & Coatings LLC in Aurora, IL, revealed a significant deficiency in their risk management processes. The firm failed to adequately document risk management activities and conduct a comprehensive risk assessment for their manufactured device. This indicates a lack of proper controls for product realization and potential product impact.
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ID · 9a1ba153-db20-48f9-ad0a-2a8322a1b73d