# FDA 483 - AstraZeneca Pharmaceuticals LP - February 26, 2016

Source: https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/438c9a60-a041-4520-80df-6f4d6acefdc7

> FDA 483 for AstraZeneca Pharmaceuticals LP on February 26, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AstraZeneca Pharmaceuticals LP
- Inspection Date: 2016-02-26
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: Pearl Therapeutics, Inc. in Redwood City, CA, an API manufacturer, was inspected and cited for significant deficiencies across its quality control, label control, employee practices, and facility maintenance. Key issues included inadequate QA oversight of samples, batch records, and repackaging, along with poor label reconciliation, improper employee gowning, and unvalidated laboratory testing and data management. Additionally, facility integrity and access control were found to be compromised.

## Related Officers

- [Lisa K. Capron](https://www.keypedia.com/people/lisa-k-capron/ebddc9f5-a5b1-4a4e-a643-7110162ec731)
- [Ashar P. Parikh](https://www.keypedia.com/people/ashar-p-parikh/f5430c51-31c7-44bb-90f7-1ec8ae581343)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/astrazeneca-pharmaceuticals-lp/cdab8252-da58-4421-a8f1-1396e3aff309

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df