SCT Incorporated – FDA Inspection, Feb 20, 2026

Record Details

This FDA Inspection record concerns SCT Incorporated, with an inspection on February 20, 2026, issued by the New Jersey District Office, covering medical devices & rad health.

Company: SCT Incorporated
Inspection Date: February 20, 2026
Product Type: Medical Devices & Rad Health
Office: New Jersey District Office
Person: Jonathan Ho (Issuing Officer)

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ID · e34b895e-4767-4aea-b2d8-ab4fffd2715b

Inspection Facts

Inspection number: 1303564
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented

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FDA Inspection

SCT IncorporatedFebruary 20, 2026