PROVISIO MEDICAL INC – FDA Inspection, Feb 27, 2026

Record Details

This FDA Inspection record concerns PROVISIO MEDICAL INC, with an inspection on February 27, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.

Company: PROVISIO MEDICAL INC
Inspection Date: February 27, 2026
Product Type: Medical Devices & Rad Health
Office: Los Angeles District Office
Person: Jenny L. Chisem (Issuing Officer)

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ID · eef3a38d-f6f5-4c97-8784-715434c84509

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1304784
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
ISO 13485:2016 Clause 8.3.2Nonconforming product was not dispositioned appropriately
ISO 13485:2016 Clause 8.5.2Corrective action not taken

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FDA Inspection

PROVISIO MEDICAL INCFebruary 27, 2026