Pulmone Advanced Medical Devices, Ltd. – FDA Inspection, Sep 22, 2022

Record Details

This FDA Inspection record concerns Pulmone Advanced Medical Devices, Ltd., with an inspection on September 22, 2022, issued by the Center for Devices and Radiological Health, covering devices.

Company: Pulmone Advanced Medical Devices, Ltd.
Inspection Date: September 22, 2022
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · b3e33f64-7a6a-4ccc-bae9-508495da4177

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1179982
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.198(c)Investigation of device failures

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FDA Inspection

Pulmone Advanced Medical Devices, Ltd.September 22, 2022