FDA Completes Inspection Of J&J Vaccine Maker Emergent BioSolutions, Cites Concerns Over Cross-Contamination, Sanitation

The U.S. Food and Drug Administration has completed its inspection of the Baltimore-based Johnson & Johnson vaccine maker Emergent BioSolutions Tuesday and “cited a number of observations concerning whether the facility’s processes met our requirements and standards.”

The FDA has been inspecting the company’s Bayview facility after it was reported that due to “human error” 15 million potential doses of the J&J coronavirus vaccine were ruined. To date, none of the Johnson & Johnson doses created at Emergent BioSolutions have been distributed in the U.S., the FDA said.

The FDA has not yet authorized Emergent to manufacture or distribute and Johnson & Johnson COVID-19 vaccines or components to date. They also recently asked the facility to pause any manufacturing while they completed their investigation.

During the inspection, the FDA “cited a number of observations concerning whether the facility’s processes met our requirements and standards.” This included a “failure to conduct thorough investigations into unexplained discrepancies” as it relates to the “cross contamination of the client viral vaccine drug substance batch with the virus from client.” They also said the cross-contamination was happening through “personal movements” by employees and that they observed the facility was not “maintained in a clean and sanitary condition.” You can see all the issues cited in the 13-page 483 form. 

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