SMD Manufacturing, LLC – FDA Inspection, Aug 27, 2026

Record Details

This FDA Inspection record concerns SMD Manufacturing, LLC, with an inspection on August 27, 2026, issued by the Denver District Office, covering medical devices & rad health.

Company: SMD Manufacturing, LLC
Inspection Date: August 27, 2026
Product Type: Medical Devices & Rad Health
Office: Denver District Office
Person: Matthew D. Schnittker (Issuing Officer)

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ID · ad2c9b62-518e-4ba9-94aa-bcb4457e0917

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1333100
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented

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FDA Inspection

SMD Manufacturing, LLCAugust 27, 2026