1Material and supplier control
Critical material used to manufacture(b)(4) is-not tracked, maintained, or replaced throughout their lifetime.
Inspection Record
Lonza AG — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Process Parameters (PPs) are not adequately controlled within established ranges iDCb><4> DS manufacturing process.
3Laboratory and QC controls
The(b)(4) (b)(4) integrity test procedure used for thc(b)(4) does not follow the vendor recommendations (documenC ,n versio~ or SOP CHVI-346656 v2.0 '~H4> IOperation of(b><4> and Integrity Test of(b><4> ~(4) {,'.
4Other quality system
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.
About this record
Extracted automatically from the document US FDA published on 2026-04-24. 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.
