TT Electronics – FDA Inspection, Jun 29, 2026

Record Details

This FDA Inspection record concerns TT Electronics, with an inspection on June 29, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.

Company: TT Electronics
Inspection Date: June 29, 2026
Product Type: Medical Devices & Rad Health
Office: Cincinnati District Office
Person: Laureen M. Geniusz (FDA Associated Person)

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ID · 122fec75-e435-4ba4-8fac-d3b93128c623

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1324154
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued, view the record

FDA Citations

ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
ISO 13485:2016 Clause 6.3Requirements for infrastructure maintenance activities not documented
ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
ISO 13485:2016 Clause 8.5.2Corrective action records not maintained

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FDA Inspection

TT ElectronicsJune 29, 2026