# FDA 483 - Regeneron Ireland Designated Activity Company - May 07, 2021

Source: https://www.keypedia.com/records/483/regeneron-ireland-designated-activity-company/b54d08fc-15d6-4b33-8cb0-c7cd05c54067

> FDA 483 for Regeneron Ireland Designated Activity Company on May 07, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regeneron Ireland Designated Activity Company
- Inspection Date: 2021-05-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Regeneron Ireland Unlimited Company, a drug substance manufacturer in Limerick, Ireland, was cited for significant deficiencies across multiple areas. These include inadequate engineering controls for electronic data integrity, insufficient personnel training and procedural detail in manufacturing, recurring microbial ingress risks from in-process leaks, and ineffective investigations and corrective actions for HEPA filter failures. The findings indicate systemic issues requiring comprehensive remediation.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/regeneron-ireland-designated-activity-company/2bd5dd2c-f511-4a52-8cf4-d76d8565274d)

## Related Officers

- [Sarah A. Johnson](https://www.keypedia.com/people/sarah-a-johnson/bb59c0e2-87ab-4958-8d33-463382ab7937)
- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)

Company: https://www.keypedia.com/companies/regeneron-ireland-designated-activity-company/74d229ed-bddb-4f75-bb07-281189fd53d4

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