# FDA 483 - Fournier Laboratories Ireland, Ltd. (Abbvie Cork) - September 12, 2023

Source: https://www.keypedia.com/records/483/fournier-laboratories-ireland-ltd-abbvie-cork/ba95cbb4-0519-4f3a-a851-546a5d98fe13

> FDA 483 for Fournier Laboratories Ireland, Ltd. (Abbvie Cork) on September 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fournier Laboratories Ireland, Ltd. (Abbvie Cork)
- Inspection Date: 2023-09-12
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Fournier Laboratories Ireland Limited in Carrigtwohill, County Cork, Ireland, revealed three significant observations. The firm was cited for inadequate in-process testing during process performance qualification, insufficient cleaning and disinfecting procedures for production rooms, and the use of a non-validated spreadsheet for critical data transformation in release testing. These issues indicate deficiencies in quality control and data integrity practices.

## Related Officers

- [Richard Ledwidge](https://www.keypedia.com/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.keypedia.com/companies/fournier-laboratories-ireland-ltd-abbvie-cork/1cceaab0-3bd3-40ff-b7e3-5b180f1fc3a4

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd