1Laboratory and QC controls
Scientifically sound test procedures are not established and followed.
Inspection Record
Regeneron Ireland Designated Activity Company — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
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.
