Dana Molded Products Inc. – FDA Inspection, May 22, 2026

Record Details

This FDA Inspection record concerns Dana Molded Products Inc., with an inspection on May 22, 2026, issued by the Chicago District Office, covering medical devices & rad health.

Company: Dana Molded Products Inc.
Inspection Date: May 22, 2026
Product Type: Medical Devices & Rad Health
Office: Chicago District Office
Person: Hammam A. Abdallah (Issuing Officer)

View Company Profile

ID · b8fe35d5-5c06-4f25-b038-f098fb1ba260

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1318408
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 4.1.4Changes to the QMS not adequately controlled or evaluated
ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
ISO 13485:2016 Clause 7.3.8Design and development transfer procedures not documented
ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented

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 Dana Molded Products Inc.

FDA Inspection

Dana Molded Products Inc.May 22, 2026