Ortho Solutions Sdn. Bhd. – FDA Inspection, May 16, 2024

Record Details

This FDA Inspection record concerns Ortho Solutions Sdn. Bhd., with an inspection on May 16, 2024, issued by the Center for Devices and Radiological Health, covering devices.

Company: Ortho Solutions Sdn. Bhd.
Inspection Date: May 16, 2024
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Thai T. Duong (Issuing Officer)

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ID · a65c23d0-d04d-413b-831b-cb1d595330da

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1240298
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
21 CFR 820.184DHR content

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FDA Inspection

Ortho Solutions Sdn. Bhd.May 16, 2024