# AstraZeneca Pharmaceuticals, LP – FDA 483, Jun 26, 2026

Source: https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/ce7746dc-c511-4f1b-bd56-ff443c055930

> FDA 483 for AstraZeneca Pharmaceuticals, LP on June 26, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AstraZeneca Pharmaceuticals, LP
- Inspection Date: 2026-06-26
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of AstraZeneca Pharmaceuticals, LP in Newark, DE, identified critical deficiencies in equipment cleaning validation and procedures. Investigators found visible drug product residues on shared manufacturing equipment that was previously documented as cleaned. These findings indicate a significant risk of cross-contamination and a failure to maintain adequate cleanliness standards in drug production.

## Related Documents

- [EIR - 2018-01-30](https://www.keypedia.com/records/eir/astrazeneca-pharmaceuticals-lp/83402cad-87aa-4a0c-a8fc-0418112367fe) — date: January 30, 2018

## Related Officers

- [Yaharn Su](https://www.keypedia.com/people/yaharn-su/75b7f7fd-d853-436e-b538-386a8c6df3cb)
- [issuing_officer](https://www.keypedia.com/people/michael-o-idowu/795647ab-8f6b-47cc-ae88-3b2c61192861)

Company: https://www.keypedia.com/companies/astrazeneca-pharmaceuticals-lp/ebec0358-60f4-4d3d-88a0-f03f946518ea

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8