# FDA 483 - AstraZeneca Pharmaceuticals LP - May 31, 2024

Source: https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/4a1a7d2c-db13-49cb-bab9-3235ea58515f

> FDA 483 for AstraZeneca Pharmaceuticals LP on May 31, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AstraZeneca Pharmaceuticals LP
- Inspection Date: 2024-05-31
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: AstraZeneca Pharmaceuticals LP in Gaithersburg, MD, was inspected regarding its corporate headquarters operations. The inspection revealed significant deficiencies in quality control, laboratory record-keeping, and complaint handling for its Beyfortus/Nirseveimab pre-filled syringes. Issues included inadequate investigations into manufacturing discrepancies, incomplete data for product quality and sterility, and insufficient oversight of third-party manufacturers and batch release.

## Related Officers

- [Jazmine N. Brown](https://www.keypedia.com/people/jazmine-n-brown/194fc53f-942f-4e8c-a475-b7eac11be103)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/ekaterina-allen/760a7817-8e5b-45f9-82ee-db6ca139a92e)
- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

Company: https://www.keypedia.com/companies/astrazeneca-pharmaceuticals-lp/f2e34b74-3ef4-4f39-8f6f-41eceb3bb779

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64