# FDA 483 - Allergan Pharmaceuticals Ireland - January 30, 2025

Source: https://www.globalkeysolutions.net/records/483/allergan-pharmaceuticals-ireland/621f52b2-bbcb-409b-ab8f-70a89c613fd3

> FDA 483 for Allergan Pharmaceuticals Ireland on January 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergan Pharmaceuticals Ireland
- Inspection Date: 2025-01-30
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Allergan Pharmaceuticals Ireland Unlimited, a drug product manufacturer in Westport, Ireland, was cited for multiple deficiencies during an FDA inspection. The observations included inadequate visual inspection rejection limits, insufficient laboratory test procedures for endotoxin, and a lack of cleaning validation for indirect product contact parts. Further issues were noted in environmental monitoring for aseptic processing areas and shipping validation for samples.

## Related Documents

- [483 - 2019-12-17](https://www.globalkeysolutions.net/records/483/allergan-pharmaceuticals-ireland/a6d431a3-55fb-4c50-9aed-4d3bedfb740c)

## Related Officers

- [Jie He](https://www.globalkeysolutions.net/people/jie-he/162aef4b-4b22-48e5-9a50-9b2e9684d589)
- [ Investigator, Consumer Safety Officer](https://www.globalkeysolutions.net/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [other](https://www.globalkeysolutions.net/people/kejun-cheng/cc135464-ed6c-4c5d-8a25-9f40ed8e2cc6)

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

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