fda_483 · inspection_citation · high

Janssen Vaccines Corporation -- FDA 483: 4 observations (2024-11-19)

Event date
2024-11-19 00:00:00Z
Observed
2026-07-12 22:32:52Z
Source ID
3012637764-2024-11-19-185510
Payload hash
1dbc409325fafb03709e3143

Summary

Observation 1: Responsibilities and procedures for quality units ai·e not in writing and/or fo llowed to ens ure the FARS (BPDR) are submitted fo r the distributed products that ai·e implicated with p...

Informational only. Not legal, financial, or medical advice.