# FDA 483 - LEO Pharma Ireland - June 24, 2022

Source: https://www.keypedia.com/records/483/leo-pharma-ireland/e9f0b464-606c-46fc-9f09-0a47ce18d194

> FDA 483 for LEO Pharma Ireland on June 24, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LEO Pharma Ireland
- Inspection Date: 2022-06-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of LEO Pharma Ireland in Dublin identified two significant observations. The firm failed to maintain adequate air pressure and dust control equipment, and its electronic records were found to be unreliable due to inconsistencies between logbook entries and the Business Management System. Additionally, the inspection revealed defects in the plumbing system, including an undetected leak, and a lack of procedures for frequent physical inspections, which could lead to drug product contamination.

## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)

Company: https://www.keypedia.com/companies/leo-pharma-ireland/59203974-017b-455b-b585-13cd35d25ed9

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1