483
Kaysersberg Pharmaceuticals SASFDA 483 - Kaysersberg Pharmaceuticals SAS - July 07, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
Kaysersberg Pharmaceuticals S.A.S., a contract manufacturer in Kaysersberg, France, was inspected by the FDA. The inspection revealed significant deficiencies in establishing the accuracy, sensitivity, and reproducibility of test methods. Additionally, the firm failed to exercise appropriate controls over computer systems, leading to concerns regarding data integrity and unauthorized changes to records.
- Person
Open in Dashboard
ID · 7ea9666e-82c7-40b1-a9c0-03ebefaa7e8e