KeriCure Inc. – FDA Inspection, Jun 11, 2026

Record Details

This FDA Inspection record concerns KeriCure Inc., with an inspection on June 11, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: KeriCure Inc.
Inspection Date: June 11, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Ulysses D. Singleton (Issuing Officer)

View Company Profile

ID · df1523c1-0d56-4e35-b7d1-5b3c167210f6

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1322752
Project area: Compliance: Devices

FDA Citations

ISO 13485:2016 Clause 7.5.8Records of validation of processes and necessary actions not maintained
ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
ISO 13485:2016 Clause 4.1.3QMS process records not established or maintained
ISO 13485:2016 Clause 7.5.6Records of validation of processes and necessary actions 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 KeriCure Inc.

FDA Inspection

KeriCure Inc.June 11, 2026