Emergent nets itself more trouble as it receives a warning letter from the FDA
Emergent BioSolutions is facing a fresh set of manufacturing troubles as the FDA issued a warning to the company regarding its Baltimore site.
Emergent revealed in an SEC filing on Friday that the US regulator issued a warning letter on Aug. 10, flagging two areas of concern at the company’s Camden manufacturing facility in Baltimore.
The FDA letter pointed to deficiencies in the Emergent plant’s systems for cleaning and maintenance of equipment to prevent contamination of drug products, specifically related to particulates from the metal trays. It also noted deficiencies in processes and practices surrounding aseptic processing.
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