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# 4 Observations on AstraZeneca FDA-483
- URL: https://www.fdaweb.com/4-observations-on-astrazeneca-fda-483/
- Published: 2025-02-25T12:00:00.000Z
- Updated: 2026-09-14T14:53:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158718

FDA has released the form FDA-483 issued following a 5/30-6/7/2024 inspection at the AstraZeneca drug manufacturing facility in Frederick, MD. The four inspection observations were:

- drug substance upstream manufacturing systems have unmitigated risk in the assurance of process performance and product quality;
- procedures in support of manufacture and the quality control test laboratory are deficient;
- failure to thoroughly document the product quality impact of quality events; and
- failure to adequately control analytical instruments in support of manufacture in assurance of data integrity.