1Deviation, CAPA, and investigation
Deviation files are incomplet.e.
Inspection Record
Genzyme Corporation — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The procedure "Surface Moni toringKb)j4) _.
3Other quality system
Portions of formulating the Fabrazyme Elution Buffer are aut.omated.
4Other quality system
On 9/17/08 rouging was seen on the outside of the chromatography column.
5Validation and qualification
Quality assurance reviewed and approved a final validation report for The Use of Bagged Serum Stoppers in Liquid Fill Finish Processes in the Fill/Finish Area at Al'lston Landing, study Kt?U4) '._~.
6Other quality system
A, Activities performed during drug substance manufacture are not adequately documented.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
