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

Source: https://www.globalkeysolutions.net/records/483/organon-pharma-uk-ltd/276787d1-49b1-4312-b31b-db090512c3cb

> FDA 483 for Organon Pharma (UK) Ltd. on June 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Organon Pharma (UK) Ltd.
- Inspection Date: 2025-06-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.globalkeysolutions.net/companies/organon-pharma-uk-ltd/5fa8cf74-45d3-45f6-abb3-6918d01961a6

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8