# FDA 483 - AstraZeneca Pharmaceuticals LP - July 22, 2022

Source: https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/cbeb85bf-3ed5-456e-9ea8-d27f7367f0b1

> FDA 483 for AstraZeneca Pharmaceuticals LP on July 22, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AstraZeneca Pharmaceuticals LP
- Inspection Date: 2022-07-22
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of AstraZeneca Pharmaceuticals LP's vaccine manufacturing facility in Philadelphia, PA, revealed significant deficiencies in aseptic processing procedures, environmental monitoring, and equipment design. The firm also failed to adequately investigate unexplained discrepancies and extend risk assessments to other affected batches. These observations indicate a need for improved controls to prevent microbiological contamination and ensure product quality.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/astrazeneca-pharmaceuticals-lp/f522475b-222d-454f-bb23-a7910b73b215)

## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.keypedia.com/companies/astrazeneca-pharmaceuticals-lp/f969afa9-62d8-4cde-8873-48180823df9b

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