# FDA 483 - Regeneron Ireland Designated Activity Company - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/regeneron-ireland-designated-activity-company/2bd5dd2c-f511-4a52-8cf4-d76d8565274d

> FDA 483 for Regeneron Ireland Designated Activity Company on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regeneron Ireland Designated Activity Company
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Regeneron Ireland Designated Activity Company, a Bulk Drug Substance Manufacturer in Limerick, Ireland, was cited for significant deficiencies in its quality unit's control of documents and records, data integrity practices, and investigation procedures. The inspection revealed issues with the retention of original GMP forms, inadequate manual integration processes, incomplete electronic data review, and insufficient investigation of deviations and HEPA filter failures. These observations indicate a systemic lack of robust quality oversight and data management.

## Related Documents

- [483 - 2021-05-07](https://www.globalkeysolutions.net/records/483/regeneron-ireland-designated-activity-company/b54d08fc-15d6-4b33-8cb0-c7cd05c54067)

## Related Officers

- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1