fda_483 · inspection_citation · high

RC Outsourcing LLC -- FDA 483: 8 observations (2025-08-28)

Event date
2025-08-28 00:00:00Z
Observed
2026-07-12 22:31:44Z
Source ID
3011967886-2025-08-28-188813
Payload hash
73e61f96c8c851855345e893

Summary

Observation 1: Investigations of a failure of a ba tch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that ...

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