# FDA 483 - Cangene BioPharma, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/cangene-biopharma-llc/6e713878-515e-4ad7-8897-24187a6d5234

> FDA 483 for Cangene BioPharma, LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cangene BioPharma, LLC
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sanofi Pasteur Biologics, LLC in Rockville, MD, a vaccine manufacturer, revealed three observations. These included deficiencies in a disinfectant efficacy study investigation, an inadequate rationale for not completing product testing, and a lack of extractables/leachables evaluation for a sterilized filling assembly. The findings indicate issues with quality control and process validation.

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Company: https://www.keypedia.com/companies/cangene-biopharma-llc/d685e3d6-8e3c-4950-b2f9-9b3aaea0df9d

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1