483
AstraZeneca ABAstraZeneca AB – FDA 483, Apr 10, 2026
Record Details
AstraZeneca AB in Sodertalje, Sweden, received a Form 483 with two observations related to inadequate quality control practices. The firm failed to thoroughly investigate unexplained discrepancies, such as foreign particles in tablet batches and recurring equipment performance issues, and its CAPA system was found to be insufficient in preventing the recurrence of deviations.
View Company Profile
ID · 9e33893b-d803-4c11-bfd7-ef205dcc19d0
Other documents for AstraZeneca AB
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.