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FDA Inspection
•Cadence Inc•September 18, 2026

Cadence Inc – FDA Inspection, Sep 18, 2026

Record Details

This FDA Inspection record concerns Cadence Inc, with an inspection on September 18, 2026, issued by the Baltimore District Office, covering medical devices & rad health.

Company
Cadence Inc
Inspection Date
September 18, 2026
Product Type
Medical Devices & Rad Health
Office
Baltimore District Office
Person
  • Tiki Dixon
View Company Profile

ID · d7bf5a0e-3597-4085-ab35-404a3e460782

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1336524
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

3
  1. ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
  2. ISO 13485:2016 Clause 7.5.6Procedures for validation of processes lack required elements
  3. ISO 13485:2016 Clause 7.6Procedures for monitoring and measuring equipment requirements not documented

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cadence Inc

1
DateClassificationOfficeProject area
December 14, 2017NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Cadence Inc
  • FDA Inspection 1040485 - 2017-12-14

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