Hubly Inc. – FDA Inspection, May 22, 2026

Record Details

This FDA Inspection record concerns Hubly Inc., with an inspection on May 22, 2026, issued by the Chicago District Office, covering medical devices & rad health.

Company: Hubly Inc.
Inspection Date: May 22, 2026
Product Type: Medical Devices & Rad Health
Office: Chicago District Office
Person: Shuana H. Xiong (Investigator)

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ID · f2724f56-ad82-4a32-b503-c1ad5dd3cbc8

Inspection Facts

Inspection number: 1318868
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
ISO 13485:2016 Clause 7.4.1Supplier performance not monitored

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FDA Inspection

Hubly Inc.May 22, 2026