© Reuters. The company logo for Johnson & Johnson is displayed on a screen to celebrate the 75th anniversary of the company’s listing at the NYSE in New York
(Reuters) – The U.S. Food and Drug Administration (FDA) said it had completed its inspection of a U.S. plant that makes Johnson & Johnson (NYSE:)’s COVID-19 vaccine and asked for remediation of issues including peeling paint and loose debris at the site.
Emergent Biosolutions (NYSE:), which owns the plant, earlier this week said it would stop production of new drug material at the plant, while the FDA conducted an inspection of the facility.
The FDA’s inspection closeout report, also known as “FDA Form 483”, cited observations including failure to train personnel to avoid cross contamination of COVID-19 vaccines from Johnson & Johnson and AstraZeneca (NASDAQ:).
The FDA also said on Wednesday the building used for manufacturing the components of the two vaccines was not of suitable size and design to facilitate cleaning and maintenance. The facility has not been authorized by the regulator to manufacture or distribute any of Johnson & Johnson’s COVID-19 vaccine or components and, to date, no vaccine manufactured at this plant has been distributed for use in the United States.
Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.
Need Your Help Today. Your $1 can change life.