FDA Issues Warning Letter to Emergent Biosolutions After February Inspection

By Kathryn Hardison

Emergent Biosolutions Inc. said the Food and Drug Administration has issued a warning letter to the company regarding deficiencies it found in a February inspection of its Camden manufacturing facility in Baltimore, Maryland.

The letter warned of issues related to Emergent's practices for aseptic processing and systems for cleaning and maintaining equipment to prevent contamination of drug product, the company said in a Friday filing with the Securities and Exchange Commission.

The FDA also recommended the company review and assess its quality management system and work with a consultant on manufacturing practices.

Emergent said Friday that it has retained a third party for additional review of the facility while it waited for the FDA's response. The company said it has made "significant investment to upgrade (its) physical capabilities."

"This is a process that doesn't happen overnight, but one to which we are committed," Emergent said.

Shares fell 4.8% to $29.01 in after-hours trading.

Write to Kathryn Hardison at [e-mail]

(END) Dow Jones Newswires

August 12, 2022 17:46 ET (21:46 GMT)

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