# FDA 483 - AstraZeneca Pharmaceuticals LP - March 19, 2021

Source: https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/b308dbbf-6bee-4596-8859-b6320002a2e9

> FDA 483 for AstraZeneca Pharmaceuticals LP on March 19, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AstraZeneca Pharmaceuticals LP
- Inspection Date: 2021-03-19
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center revealed significant deficiencies across its operations. The firm failed to ensure the quality control unit's responsibilities were fully followed, including issues with electronic system validation and supplier material testing. Additionally, the facility demonstrated inadequate microbial control in drug substance manufacturing and failed to conduct thorough investigations into deviations and out-of-specification results.

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## Related Officers

- [Zhao Wang, Chemist, Ph.D.](https://www.keypedia.com/people/zhao-wang-chemist-phd/5c97ae2a-0968-4e26-8785-4854d8503d05)
- [FDA Biologics Investigator](https://www.keypedia.com/people/viviana-matta/6fecf0ca-0edc-4538-a57e-72642f41b5c7)
- [Haohong Yan, Lead Chemist, Ph.D.](https://www.keypedia.com/people/haohong-yan-lead-chemist-phd/d0059cc8-8f07-4a82-8533-f920dca79017)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd