FDA inspection of Emergent’s Baltimore site in 2020 raises new questions
The FDA on Thursday raised fresh quality concerns about Emergent BioSolutions’ manufacturing site in Baltimore, which has more recently been taken over by J&J after an error caused the site to discard about 15 million doses of the company’s vaccine last month.
According to a Form 483 issued to the contract testing lab last April, following a 7-day inspection and just released by the FDA, Emergent’s quality unit failed to ensure some very basic, fundamental activities, like that staff couldn’t just delete or manipulate electronic data, and the responsibilities and procedures for the quality unit were not in writing or fully followed, FDA said.
“At the time of this inspection, no investigations had been performed to assess the impact of the data deletions, modifications or the failure to review system audit trails on drug substance and drug product analyzed until approximately, December 2019,” the Form 483 signed by FDA investigator Marcellinus Dordunoo says.
What’s more, the 483 highlights the site’s inability to prevent mix-ups of ingredients or contamination. The site’s mix-up of J&J and AstraZeneca drug substance is what caused the millions of doses to be thrown out.
“Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components before disposition,” FDA said.
The company’s computers also did not prevent users from changing the system date and time, meaning they could alter previous work as though they were working in real time.
“During the biochemistry laboratory walk-through, it was observed that the present time-zone and subsequently, the date and time was able to be modified,” FDA notes. The agency also found employees working in the site’s biochemistry lab who were not documented as being trained on the firm’s written procedures or test methods.
Another observation notes that sample identification numbers “were observed to be manually corrected, multiple days after data acquisition” and the company did not perform an investigation.
The Form 483 offers a peek behind the curtain on a site that has garnered lots of recent negative attention. Last Saturday, AstraZeneca, under the direction of the US government, announced that it will relocate production of its vaccine drug substance from the Emergent facility, but has yet to announce a new site. Novavax also previously relocated production of its vaccine from Emergent to Fujifilm.
Another outside report on the site from last June, first explained in detail by the New York Times, noted the factory’s problems “will require significant effort,” and the company “will have to be monitored closely.”
An Emergent spokesperson said in a statement, “We have worked and continue to work closely with the federal government in support of the COVID response. These FDA observations were addressed and reviewed in detail with FDA during their recent site visits in September 2020 and February 2021.”