FDA Inspection
Surface Guard Films LLCSurface Guard Films LLC – FDA Inspection, Jun 3, 2026
Record Details
This FDA Inspection record concerns Surface Guard Films LLC, with an inspection on June 3, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c1e059c6-09a9-4c6f-b889-605d36aa1ca6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1321418
- Project area
- Compliance: Devices
FDA Citations
1- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
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Other FDA inspections of Surface Guard Films LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 8, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Surface Guard Films LLC
- FDA Inspection 1053013 - 2018-04-05
- FDA Inspection 901011 - 2014-07-08
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