Robotic Precision Therapy, LLC. – FDA Inspection, May 22, 2026

Record Details

This FDA Inspection record concerns Robotic Precision Therapy, LLC., with an inspection on May 22, 2026, issued by the Detroit District Office, covering medical devices & rad health.

Company: Robotic Precision Therapy, LLC.
Inspection Date: May 22, 2026
Product Type: Medical Devices & Rad Health
Office: Detroit District Office
Person: David J. Gasparovich (Issuing Officer)

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ID · e0174465-3826-4d6c-a3cd-85147270d1cb

Inspection Facts

Inspection number: 1318364
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product

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FDA Inspection

Robotic Precision Therapy, LLC.May 22, 2026