FDA 483 - AstraZeneca Pharmaceuticals LP - February 26, 2016

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.