# FDA 483 - Emergent BioSolutions Canada Inc. - July 18, 2014

Source: https://www.globalkeysolutions.net/records/483/emergent-biosolutions-canada-inc/b82b9b70-5da7-4766-874a-f0d400f4d797

> FDA 483 for Emergent BioSolutions Canada Inc. on July 18, 2014. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emergent BioSolutions Canada Inc.
- Inspection Date: 2014-07-18
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Cangene Corporation dba Emergent Biosolutions, a manufacturer in Winnipeg, Canada, was cited for numerous deficiencies during an FDA inspection. The observations highlight significant issues across quality systems, including inadequate investigations, poor microbiological contamination control for sterile products, facility design flaws, and insufficient equipment maintenance. These findings indicate a broad lack of adherence to good manufacturing practices, posing potential risks to product quality and patient safety.

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Company: https://www.globalkeysolutions.net/companies/emergent-biosolutions-canada-inc/b307e34c-3470-4633-86ab-237341dae46c

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