# FDA 483 - Allergan Pharmaceuticals Ireland - December 17, 2019

Source: https://www.globalkeysolutions.net/records/483/allergan-pharmaceuticals-ireland/a6d431a3-55fb-4c50-9aed-4d3bedfb740c

> FDA 483 for Allergan Pharmaceuticals Ireland on December 17, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergan Pharmaceuticals Ireland
- Inspection Date: 2019-12-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Allergan Pharmaceuticals Ireland in Westport, County Mayo, Ireland, identified significant deficiencies in quality control and manufacturing processes. Observations included inadequate visual inspection and AQL programs for injectable products, failure to properly sanitize a fill line after a repair, and issues with equipment calibration and utility qualification. These findings indicate a need for improved controls to ensure drug product quality and purity.

## Related Documents

- [483 - 2025-01-30](https://www.globalkeysolutions.net/records/483/allergan-pharmaceuticals-ireland/621f52b2-bbcb-409b-ab8f-70a89c613fd3)

## Related Officers

- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.globalkeysolutions.net/companies/allergan-pharmaceuticals-ireland/b65756b6-b7d5-438c-a312-93abdd3b372d

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