483
Surface Guard Films LLCSurface Guard Films LLC – FDA 483, Jun 3, 2026
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.
- Office
- Chicago District Office
- Person
View Company Profile
ID · 9a1ba153-db20-48f9-ad0a-2a8322a1b73d
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.