# FDA 483 - Emergent BioSolutions Canada Inc. - August 27, 2025

Source: https://www.keypedia.com/records/483/emergent-biosolutions-canada-inc/81de55ca-3e72-47fe-9345-095c9efe421f

> FDA 483 for Emergent BioSolutions Canada Inc. on August 27, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emergent BioSolutions Canada Inc.
- Inspection Date: 2025-08-27
- Product Type: biologics
- Office Name: Office of Pharmaceutical Manufacturing Assessment
- Summary: Emergent BioSolutions Canada Inc. underwent an FDA inspection from August 19 to August 27, 2025, revealing significant concerns regarding procedures designed to prevent microbiological contamination during the manufacturing of sterile drug products. The observations, documented in an FDA Form 483, highlight several critical deficiencies in their control over the aseptic processing environment. Key issues identified include the absence of adequate monitoring for operators working in sterile processing areas, specifically concerning gowning practices and potential contaminant introduction during cleaning. Inspectors observed manufacturing personnel with exposed skin and touching non-sterile surfaces without subsequent glove sanitization, posing a direct risk of contamination. Furthermore, cleaning protocols for critical equipment after exposure to less controlled environments during pre-filling setups were found to be insufficient. The firm also failed to demonstrate unidirectional airflow in critical processing zones through smoke studies and lacked environmental monitoring during various stages of filling operations. These observations indicate a need for immediate and comprehensive corrective actions by Emergent BioSolutions Canada Inc. to ensure compliance with good manufacturing practices for sterile products. The company is expected to develop and implement robust procedures, enhance operator training and monitoring, and validate environmental controls to prevent contamination risks and safeguard product quality and patient safety.

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## Related Officers

- [Laurimer X. Kauian-Torres](https://www.keypedia.com/people/laurimer-x-kauian-torres/0be42c7a-e6c6-435e-bf56-74ca7fe413ec)

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-manufacturing-assessment/fe47b0bd-c1c6-4458-a8c9-15e4b073d3df