# FDA 483 - AbbVie Ireland NL. B.V. - September 10, 2024

Source: https://www.keypedia.com/records/483/abbvie-ireland-nl-bv/3e2598bf-a322-4d24-bb63-a1ec5157e639

> FDA 483 for AbbVie Ireland NL. B.V. on September 10, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AbbVie Ireland NL. B.V.
- Inspection Date: 2024-09-10
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Abbvie Ireland NL B.V Ballytivnan in Sligo identified multiple significant deficiencies across its drug product manufacturing operations. Observations included inadequate procedures for preventing microbial contamination, insufficient visual inspection processes, and a deficient environmental monitoring program. The facility also exhibited poor maintenance, unqualified storage areas, and a lack of adherence to established SOPs, indicating a broad range of non-compliance issues that could impact product quality and sterility.

## Related Officers

- [Ayyappan Rathakrishnan](https://www.keypedia.com/people/ayyappan-rathakrishnan/4f1e717b-5d46-4f94-83c8-59eff245cc44)
- [Hamet Touré, PharmD MPH](https://www.keypedia.com/people/hamet-toure-pharmd-mph/611bd66b-e975-4be5-9ac5-7a2ee17bfd91)
- [other](https://www.keypedia.com/people/hamet-m-toure/9f3726f3-b118-4247-9793-738557aa1ee8)

Company: https://www.keypedia.com/companies/abbvie-ireland-nl-bv/d26b61d9-4a9b-4352-9400-043b23ba5d10

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