Inspection Record

Regeneron Ireland Designated Activity Company — FDA 483 Findings

US FDAInspected 2023-03-14Published 2024-11-22 6 findingsLaboratory and QC controlsOther quality systemDeviation, CAPA, and investigationQuality unit oversightEquipment and facility

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory and QC controls

Scientifically sound test procedures are not established and followed.

2Other quality system

Control records do not contain complete data derived from all tests.

3Deviation, CAPA, and investigation

Deviations from established procedures are not thoroughly investigated.

4Quality unit oversight

The quality unit did not ensure issuance of documents is controlled and original records are maintained.

5Equipment and facility

Air handling systems are not appropriately monitored and appropriate action is not taken when limits are exceeded.

6Quality unit oversight

Data is not thoroughly reviewed by the quality unit.

About this record

Extracted automatically from the document US FDA published on 2024-11-22. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Regeneron Ireland Designated Activity Company company profile — full history US FDA documents, 2024 Go to Findings search