Glycar SA Pty., Ltd. – FDA Inspection, Aug 10, 2017

Record Details

This FDA Inspection record concerns Glycar SA Pty., Ltd., with an inspection on August 10, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Glycar SA Pty., Ltd.
Inspection Date: August 10, 2017
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Christine I. Shaw (Company Rep)

View Company Profile

ID · 2d58c84d-d8cf-490c-b54c-410f7e0976f7

Inspection Facts

Inspection number: 1021054
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.72(a)Equipment suitability & capability
21 CFR 820.75(a)Lack of or inadequate process validation

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 Glycar SA Pty., Ltd.

FDA Inspection

Glycar SA Pty., Ltd.August 10, 2017