FDA Inspection 1314406 - APMTD, INC. - April 28, 2026

Record Details

This FDA Inspection record concerns APMTD, INC., with an inspection on April 28, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: APMTD, INC.
Inspection Date: April 28, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: James P. Finn (Company Rep)

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ID · 8777910c-77ed-497c-bdbb-bd3109d39cfd

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1314406
Project area: Compliance: Devices

FDA Citations

ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented

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FDA Inspection

APMTD, INC.April 28, 2026