# FDA 483 - Cangene bioPharma, LLC., dba Emergent BioSolutions - Unknown Date

Source: https://www.keypedia.com/records/483/cangene-biopharma-llc-dba-emergent-biosolutions/529407aa-fafd-4cad-8b82-c5752c9e758e

> FDA 483 for Cangene bioPharma, LLC., dba Emergent BioSolutions on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cangene bioPharma, LLC., dba Emergent BioSolutions
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Cangene bioPharma, LLC., dba Emergent BioSolutions in Rockville, MD, a drug (vaccine) manufacturer, revealed significant deficiencies in sterile manufacturing procedures, including inadequate gowning, isolator cleaning, and aseptic process simulation documentation. The inspection also cited unjustified deviations from production procedures, such as issues with visual inspection of ACAM2000 vials, and a failure to investigate persistent mold contamination within the facility. These observations indicate a moderate to severe level of non-compliance impacting product quality and safety.

## Related Officers

- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)

Company: https://www.keypedia.com/companies/cangene-biopharma-llc-dba-emergent-biosolutions/5c501504-b977-46ca-8235-0016e9e7bdd1

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e