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# Emergent Details New Quality Enhancement Plan
- URL: https://www.fdaweb.com/emergent-details-new-quality-enhancement-plan/
- Published: 2021-07-15T12:00:00.000Z
- Updated: 2026-09-14T17:06:26.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149720

Emergent Biosolutions says it is establishing a quality enhancement plan for its troubled Bayview manufacturing facility in Baltimore, MD. A just-released 4/30 [submission](https://www.fda.gov/media/150657/download?ref=fdaweb.com) to FDA was the company’s initial response to an [FDA-483](https://www.fdaweb.com/emergent-bio-covid-vaccine-9-item-fda-form-483/) that detailed nine concerns at the facility. The agency inspection followed reports of cross-contamination between Johnson & Johnson and AstraZeneca Covid-19 vaccines.

Emergent says it “knows that it must do everything within its power to ensure appropriate controls are in place to assure product quality.” It says its new plan will **(1)** implement enhanced contamination controls at the Bayview facility before starting new production; **(2)** institute effective interim controls, including Emergent corporate quality, J&J, and independent third-party oversight and monitoring; and **(3)** guide the development and execution of continuous improvement initiatives.

“Emergent believes that the implementation of the activities described below fully addresses the 483 observations and ensures that adequate controls are in place to support resumption of manufacturing at the Bayview facility and authorization of the Bayview facility to manufacture drug substance for the Janssen Covid-19 vaccine under the existing Janssen emergency use authorization,” the response says.