Jeisys Medical Co., Ltd. – FDA Inspection, May 25, 2017

Record Details

This FDA Inspection record concerns Jeisys Medical Co., Ltd., with an inspection on May 25, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Jeisys Medical Co., Ltd.
Inspection Date: May 25, 2017
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Kwong P. Lee (Company Rep)

View Company Profile

ID · c4d821ec-3bf7-4b43-a0c9-d47b558f9fd5

Inspection Facts

Inspection number: 1014687
FDA center: Medical Devices & Rad Health
Project area: Radiation Control and Health Safety Act
Outcome: Form 483 issued

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.184DHR content
21 CFR 820.75(a)Documentation

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 Jeisys Medical Co., Ltd.

FDA Inspection

Jeisys Medical Co., Ltd.May 25, 2017