1Equipment and facility
Procedures for cleaning of the equipment and facility are not established and followed.
Inspection Record
Bayer AG Pharma — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Failure to perform a thorough investigation into a discrepancy.
3Equipment and facility
Facilities and equipment are not of a suitable design for their intended use.
4Other quality system
Procedures to ensure reliable detection of particulate matter in parenteral products have not been established.
5Contamination control
Failure to establish separate areas to prevent cross contamination.
6Other quality system
Failure to maintain and review all analytical data.
7Complaint and recall handling
Failure to conduct thorough complaint investigations and extend the investigation to related batches.
8Laboratory and QC controls
Test procedures for analytical testing have not been established.
9Other quality system
A document control system has not been established.
About this record
Extracted automatically from the document US FDA published on 2017-02-22. 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.
