Altor Safety – FDA Inspection, Mar 12, 2026

Record Details

This FDA Inspection record concerns Altor Safety, with an inspection on March 12, 2026, issued by the New York District Office, covering medical devices & rad health.

Company: Altor Safety
Inspection Date: March 12, 2026
Product Type: Medical Devices & Rad Health
Office: New York District Office
Person: Andrew J. Garufi (Issuing Officer)

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ID · 530c9835-9a49-426e-97a9-a9a83eebdc6b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1307052
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 803.17Lack of Written MDR Procedures
ISO 13485:2016 Clause 7.5.8Process for production and service provision not validated
ISO 13485:2016 Clause 4.2.3Medical device file not established and maintained
ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
ISO 13485:2016 Clause 7.3.10Design and development files not maintained
ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated

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FDA Inspection

Altor SafetyMarch 12, 2026