Organon Pharma (UK) Ltd.June 13, 2025

FDA 483 - Organon Pharma (UK) Ltd. - June 13, 2025

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 Organon Pharma (UK) Ltd.

Record Details

An FDA inspection of Organon Pharma (UK) Ltd. in Cramlington, United Kingdom, a drug manufacturer, revealed three significant observations. Deficiencies included inadequate testing of components used in drug product manufacturing, failure to follow quality control unit procedures for labeling rejected materials, and insufficient cleaning validation studies for non-dedicated equipment, potentially leading to contamination.

Company: Organon Pharma (UK) Ltd.
Inspection Date: June 13, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Khoa Nathan V. Tran (issuing_officer)

Open in Dashboard

ID · 276787d1-49b1-4312-b31b-db090512c3cb