NextBeam – FDA Inspection, Mar 13, 2025

Record Details

This FDA Inspection record concerns NextBeam, with an inspection on March 13, 2025, issued by the Minneapolis District Office, covering medical devices & rad health.

Company: NextBeam
Inspection Date: March 13, 2025
Product Type: Medical Devices & Rad Health
Office: Minneapolis District Office
Person: Clifford F. Long (Issuing Officer)

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ID · 32880e87-ce31-4561-b382-98da680ea4eb

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1263631
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 803.17Lack of Written MDR Procedures

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FDA Inspection

NextBeamMarch 13, 2025