fda_483 · inspection_citation · high

Lonza AG -- FDA 483: 3 observations (2025-10-28)

Event date
2025-10-28 00:00:00Z
Observed
2026-07-12 22:31:33Z
Source ID
3002930340-2025-10-28-192134
Payload hash
d7f418db07931bc98f36d549

Summary

Observation 1: The information provided by the firm does not conform to the{b)(4) ~cifically , in the H4> the(b)(4) drug substance (DS) shelflife iS (bH4> at :$(b><4> C. However, the shelflife applied...

Entities

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