# FDA 483 - AstraZeneca AB - April 10, 2026

Source: https://www.keypedia.com/records/483/astrazeneca-ab/9e33893b-d803-4c11-bfd7-ef205dcc19d0

> FDA 483 for AstraZeneca AB on April 10, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AstraZeneca AB
- Inspection Date: 2026-04-10
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: 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.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/astrazeneca-ab/d8eec4ea-3b13-4094-9a24-d39824562c53)

## Related Officers

- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Allison A. Aldridge](https://www.keypedia.com/people/allison-a-aldridge/bdf1154e-481c-4229-b720-c1261af9bcb7)

Company: https://www.keypedia.com/companies/astrazeneca-ab/b85a1aa5-9a0c-4c1e-996d-70b40b2507de

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3