1Material and supplier control
Rejected materials are not always controlled under a quarantine/hold classification in SAP system to prevent their unauthorized use.
Inspection Record
Rentschler Biopharma SE — FDA 483 Findings
Inspectors Jose M. Melendez · Wayne Seifen · Ralph BernsteinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
4 Cleaned and pending use (b) < > nd (b) <4> have rings of discoloration below the top of the (b)l..J) assembly.
3Laboratory and QC controls
Laboratory procedures or testing to assure compliance with established specifications and standards is not available.
4Equipment and facility
Your firm failed to establish an adequate system for monitoring environmental conditions of critical process equipment.
5Equipment and facility
Equipment and facility systems in support of manufacture have not been adequately validated.
6Other quality system
Procedural controls in support of manufacture are not foll owed.
7Equipment and facility
Facilities and equipment in support of manufacture arc not adequately maintained.
About this record
Extracted automatically from the document US FDA published on 2022-06-10. 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.
