UPDATED: 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.
The warning letter from the FDA said that most of the tray units at the facility have suffered apparent damage and were also inadequate for use in sterile drug production. Emergent also lacked any specifics regarding its document activities for the inspection, identification, segregation, evaluation, repair or retirement of defective tray units.
While Emergent stated to the FDA that it improvements to the program monitoring aseptic processing personnel behavior and classroom training on aseptic behaviors the US regulator found that that response was not adequate.
The FDA recommended to Emergent that it should review and assess its quality management system and engage a consultant to go over the company’s CGMP operations. In the SEC filing, Emergent said it retained a third party to conduct an additional review of the facility and to provide oversight of ongoing processes at the Camden site.
“Biopharmaceutical manufacturing is complex, and the stakes are high. That is why we have made significant investments to upgrade our physical capabilities and are focused on strengthening our culture of quality and compliance. This is a process that doesn’t happen overnight, but one to which we are committed,” according to a statement from Emergent.
Emergent did not respond to any further inquiries from Endpoints News.
However, this is not the first time the Maryland-based manufacturer has crossed paths with the FDA. In April 2021, Emergent had to shut down production at its Bayview facility and quarantine any existing materials in the wake of a Johnson & Johnson vaccine manufacturing fiasco. At the time, FDA investigators found the company’s quality unit failed to ensure basic functions of its operations, including electronic data that were manipulated and deleted, and quality unit procedures that had not been put into writing, among an array of other issues.
And it’s not the only problem that Emergent is dealing with. Last month, Emergent claimed that J&J that it will have to pay somewhere in the range of $125 million to $420 million if J&J terminates its Covid manufacturing contract as the Big Pharma winds down its Covid-19 vaccine operations before fulfilling the minimum requirements in its contract with Emergent.
Additional Emergent manufacturing issues around the J&J vaccine also are being revealed in new congressional committee findings released last Thursday. It showed that 135 million more coronavirus vaccine doses manufactured at Emergent’s Baltimore-based facility for J&J were designated for destruction due to quality deficiencies. That brings the total number of doses wasted to north of 525 million.
Emergent has 15 days from Aug. 10 to respond to the FDA and they are encouraged to correct any violations promptly. Failure to address the matter may result in regulatory or legal action or the withholding of export certificates, among other actions.