# FDA 483 - AstraZeneca Pharmaceuticals, LP - January 30, 2018

Source: https://www.globalkeysolutions.net/records/483/astrazeneca-pharmaceuticals-lp/802dcb0f-4c3f-4e36-b64f-e85ed202036f

> FDA 483 for AstraZeneca Pharmaceuticals, LP on January 30, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AstraZeneca Pharmaceuticals, LP
- Inspection Date: 2018-01-30
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: AstraZeneca Pharmaceuticals, LP in Gaithersburg, MD, was inspected from January 25-30, 2018. The inspection revealed a significant compliance issue where the firm failed to report all serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days. This indicates deficiencies in their pharmacovigilance reporting processes.

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.globalkeysolutions.net/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)

Company: https://www.globalkeysolutions.net/companies/astrazeneca-pharmaceuticals-lp/aa429465-30b1-4dd2-bd35-6d8b6daa8a37

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e