Emergent Receives FDA Warning Letter Over Quality Control Issues

Emergent Receives FDA Warning Letter Over Quality Control Issues
Signage outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters
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Emergent BioSolutions Inc. said on Friday it had received a warning letter from the Food and Drug Administration (FDA), citing certain deficiencies at the contract drugmaker’s manufacturing facility in Baltimore, Maryland.

The FDA pointed to deficiencies in cleaning and maintenance of equipment to prevent contamination of drug product and also recommended the company review its quality control process, Emergent said.