# FDA 483 - ABBOTT IRELAND LIMITED - March 14, 2025

Source: https://www.globalkeysolutions.net/records/483/abbott-ireland-limited/9bbd95fb-b35c-4fe9-b495-824a1814102c

> FDA 483 for ABBOTT IRELAND LIMITED on March 14, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABBOTT IRELAND LIMITED
- Inspection Date: 2025-03-14
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: Abbott Ireland, an infant formula manufacturer in Cootchill, Cavan, was cited for significant deficiencies in its process controls, leading to the adulteration of infant formula with Cronobacter sakazakii. The inspection revealed finished product positives, widespread environmental contamination, numerous water events in high-care areas, and inadequate hygienic zoning controls, indicating a severe breakdown in sanitation and pathogen prevention systems.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/raymond-m-lam/f2414f9c-832b-40df-9b7e-cfa302645204)

Company: https://www.globalkeysolutions.net/companies/abbott-ireland-limited/c71cf560-250a-47af-8ed2-c099e113ce5b

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