1Other quality system
Quality Assurance oversight ofcontrol processes is insufficient: • Cerezyme release specifications for drug substance and drug product do not reflect manufacturing history and process capability.
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 quality group has not approved all as-built drawings and floor plans on site.
3Other quality system
The firm uses wet lines for their sprinkler system.
4Other quality system
Some procedures reviewed are not reflective of the firm's current practice.
5Material and supplier control
For raw material: • There is no tracking or trending offailed incoming raw materials.
6Process validation
Process validation is incomplete: (b) (4) • Microfiltration skid membrane for Cerezyme manufacturing is not validated for its reuse.
7Training and personnel
Training of employees is insufficient in that: • Personnel are performing routine job functions without being trained on the current approved procedures.
8Other quality system
Cerezyme manufacturing process has not been updated to reflect cGMP's.
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.
