483
Fournier Laboratories Ireland, Ltd. (Abbvie Cork)Fournier Laboratories Ireland, Ltd. (Abbvie Cork) – FDA 483, Sep 12, 2023
Record Details
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.
- Inspection date
- September 12, 2023
- Product type
- drugs
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ID · ba95cbb4-0519-4f3a-a851-546a5d98fe13
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