BIONICM – FDA Inspection, Aug 20, 2026

Record Details

This FDA Inspection record concerns BIONICM, with an inspection on August 20, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: BIONICM
Inspection Date: August 20, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Alex J. Wild (Issuing Officer)

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ID · 7758747d-0947-4f03-aba0-fcc9bff1efe5

Inspection Facts

Inspection number: 1335880
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)

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FDA Inspection

BIONICMAugust 20, 2026