# FDA 483 - AstraZeneca Pharmaceuticals LP - January 19, 2023

Source: https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/05295a30-e31b-4220-a8bf-8906643f78cd

> FDA 483 for AstraZeneca Pharmaceuticals LP on January 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AstraZeneca Pharmaceuticals LP
- Inspection Date: 2023-01-19
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: AstraZeneca Pharmaceuticals LP in Frederick, MD, a drug substance manufacturer, received a Form 483 with two observations. The inspection revealed issues with computer system controls, specifically alterable date/time stamps on systems used for drug substance testing, and inadequate use of sporicidal agents in ISO 5 classified processing areas due to unsupported contact times. These findings indicate significant concerns regarding data integrity and environmental control.

## Related Documents

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- [WARNING_LETTER - 2023-08-15](https://www.keypedia.com/records/warning_letter/astrazeneca-pharmaceuticals-lp/ffb41aa4-e9b4-4e4e-b72f-9cf78acb857c)
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## Related Officers

- [Sena G. Dissmeyer](https://www.keypedia.com/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/astrazeneca-pharmaceuticals-lp/6f9abb75-9352-43df-b761-026089396fa3

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