Mariola Smotrys MD, MBA, MSc – FDA Inspection, Sep 3, 2026

Record Details

This FDA Inspection record concerns Mariola Smotrys MD, MBA, MSc, with an inspection on September 3, 2026, issued by the Philadelphia District Office, covering medical devices & rad health.

Company: Mariola Smotrys MD, MBA, MSc
Inspection Date: September 3, 2026
Product Type: Medical Devices & Rad Health
Office: Philadelphia District Office
People: Brittany M. Kershaw (Issuing Officer)
Mishelle L. Harriger (Company Rep)

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ID · 220de904-3bcf-4e13-b131-d76518bc7e9b

Inspection Facts

Inspection number: 1335528
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 50.20Circumstances of obtaining consent
21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
21 CFR 50.27(a)Consent form not approved/signed/dated

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FDA Inspection

Mariola Smotrys MD, MBA, MScSeptember 3, 2026