Starch Medical Inc. – FDA Inspection, Aug 26, 2026

Record Details

This FDA Inspection record concerns Starch Medical Inc., with an inspection on August 26, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.

Company: Starch Medical Inc.
Inspection Date: August 26, 2026
Product Type: Medical Devices & Rad Health
Office: Center for Devices and Radiological Health
Person: Brittany D. Mccracken (Issuing Officer)

View Company Profile

ID · f5b7b932-c754-4d19-916a-5ed152f27be4

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1333042
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
ISO 13485:2016 Clause 6.2(a)Records of personnel competence not maintained
ISO 13485:2016 Clause 6.2(e)Records of personnel competence not maintained

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Starch Medical Inc.

FDA Inspection

Starch Medical Inc.August 26, 2026