AstraZeneca AB
Form 483 issued April 10, 2026
- Inspection
- Apr 7 – Apr 10, 2026
- Observations
- 2
- Pages
- 2
- FEI number
- 3003342394
In short: On April 10, 2026, FDA issued a Form 483 with 2 observations to AstraZeneca AB (FEI 3003342394) after an inspection that ran Apr 7 – Apr 10, 2026.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Questions about this 483
What did FDA find at AstraZeneca AB?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
When was AstraZeneca AB inspected by FDA?
The inspection ran Apr 7 – Apr 10, 2026, and the Form 483 is dated April 10, 2026.
How do I get the full Form 483 for AstraZeneca AB?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.