Cordica Medical (formerly Team Technologies Molding) – FDA Inspection, Jun 8, 2026

Record Details

This FDA Inspection record concerns Cordica Medical (formerly Team Technologies Molding), with an inspection on June 8, 2026, issued by the Chicago District Office, covering medical devices & rad health.

Company: Cordica Medical (formerly Team Technologies Molding)
Inspection Date: June 8, 2026
Product Type: Medical Devices & Rad Health
Office: Chicago District Office
Person: Jesse A. Vazquez (FDA Associated Person)

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ID · c9f42f4a-79e3-44da-b561-4cb78aec7e03

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1320974
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued, view the record

FDA Citations

ISO 13485:2016 Clause 4.2.1QMS documentation does not include required documents
ISO 13485:2016 Clause 6.2(e)Records of personnel competence not maintained
ISO 13485:2016 Clause 7.1Processes needed for product realization not planned and developed

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FDA Inspection

Cordica Medical (formerly Team Technologies Molding)June 8, 2026