Raumedic Inc – FDA Inspection, Mar 13, 2026

Record Details

This FDA Inspection record concerns Raumedic Inc, with an inspection on March 13, 2026, issued by the Atlanta District Office, covering medical devices & rad health.

Company: Raumedic Inc
Inspection Date: March 13, 2026
Product Type: Medical Devices & Rad Health
Office: Atlanta District Office
Person: Alex J. Wild (Issuing Officer)

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ID · fb02bcf7-682d-4f71-8214-63201d32baf9

Inspection Facts

Inspection number: 1308010
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

ISO 13485:2016 Clause 7.4.3Records of purchased product verification not maintained
ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
ISO 13485:2016 Clause 7.5.6Procedures for validation of processes lack required elements

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FDA Inspection

Raumedic IncMarch 13, 2026