fda_483 · inspection_citation · high

Biocon Biologics Limited -- FDA 483: 5 observations (2025-09-03)

Event date
2025-09-03 00:00:00Z
Observed
2026-07-12 22:31:44Z
Source ID
3015283245-2025-09-03-190615
Payload hash
2348e14e8912924bb0f408e4

Summary

Observation 1: Written sanitation and facility maintenance procedures are not established or followed. Specifically, A) Th~ '---,,------,----,.----·-- " .::..:..:_ ;process facility maintenance and cl...

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