# FDA 483 - Surface Guard Films LLC - June 03, 2026

Source: https://www.keypedia.com/records/483/surface-guard-films-llc/9a1ba153-db20-48f9-ad0a-2a8322a1b73d

> FDA 483 for Surface Guard Films LLC on June 03, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surface Guard Films LLC
- Inspection Date: 2026-06-03
- Product Type: other
- Office Name: FDA District Office — Chicago, Illinois
- Summary: 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.

## Related Officers

- [Shawn Choi](https://www.keypedia.com/people/shawn-choi/77845db3-46a3-4d0f-b94c-428bc251c0dc)

Company: https://www.keypedia.com/companies/surface-guard-films-llc/dd22a0b0-8943-4c29-aecc-3dd20d533bec

Office: https://www.keypedia.com/offices/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65