GLPGCP Development (Asia) Pte. Ltd.April 19, 2018

FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - April 19, 2018

View on Dashboard

Discuss this record with AI

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 GLPGCP Development (Asia) Pte. Ltd.

Record Details

An FDA inspection of Humanoptics Ag., a manufacturer in Sankt Augustin, Germany, identified two significant issues. The firm was cited for inadequate validation of processes where results cannot be fully verified by subsequent inspection and test. Additionally, procedures for corrective and preventive action were found to be inadequately established.

Company: GLPGCP Development (Asia) Pte. Ltd.
Inspection Date: April 19, 2018
Product Type: Device
Office: Office of Inspections and Investigations
Person: Maryam Tabatabaie (issuing_officer)

Open in Dashboard

ID · 4fd7e91c-468e-4aed-8198-505eaef4128a