COMPASS INNOVATIONS INC – FDA Inspection, Aug 4, 2026

Record Details

This FDA Inspection record concerns COMPASS INNOVATIONS INC, with an inspection on August 4, 2026, issued by the San Francisco District Office, covering medical devices & rad health.

Company: COMPASS INNOVATIONS INC
Inspection Date: August 4, 2026
Product Type: Medical Devices & Rad Health
Office: San Francisco District Office
Person: Wendy M. Stone (Company Rep)

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ID · b29e72d4-8522-4078-9a1b-48d23b7a109b

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1329284
FDA center: Medical Devices & Rad Health
Project area: Radiation Control and Health Safety Act
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated

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FDA Inspection

COMPASS INNOVATIONS INCAugust 4, 2026