BALTIMORE (WJZ) -- 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.
In a press release Wednesday, the FDA said it "takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency's standards for quality, safety and effectiveness."
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 that concern how the plant processes its products. 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." They also cited things like paint peeling and how waste was handled. You can see all the issues cited in the 13-page 483 form.
"That is concerning.. and I think what we have to understand is that the FDA does inspect vaccine manufacturers and have very stringent requirements around manufacturer," said Anna Durbin, MD, professor in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health.
The FDA's observations intend to help identify certain conditions that could have led to quality control issues at the plant.
"Once we observe such conditions, we can then work with a company to help identify a path forward to remedy the issues," the FDA said.
"Indeed, it is often in the public's best interest that the FDA work with firms to quickly resolve compliance matters to ensure that the public has access to medical products that meet the agency's high standards for quality, safety and effectiveness," the FDA added in their statement.
The FDA is working with Emergent BioSolutions to address the conditions identified. Their products will undergo more testing and be evaluated before potential distribution.
"We will not allow the release of any product until we feel confident that it meets our expectations for quality, the FDA said.
This inspection is unrelated to an ongoing evaluation of the Johnson & Johnson vaccine being possibly linked to an extremely rare case of a blood clot reported in six women, between the ages of 18 and 48, after they received the one-dose shot.
"We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency's high standards for quality, safety and effectiveness," the FDA said. "We know that every time an American, including members of our own families, receives a COVID-19 vaccine dose, they are putting their trust in us. We are working hard to maintain that trust."
The House Oversight Committee opened an investigation into whether Emergent BioSolutions used a tie with a Trump official to profit off of federal contracts. The CEO is expected to testify in front of the committee.
Wednesday afternoon, Gov. Larry Hogan revealed he recently discussed the issues at Emergent with White House officials.
"Sounds like they inspect these facilities every two years," he said. "They were very hopeful on Emergent and J&J, and their story to us was that they hoped by Friday that this decision would be made."
Dr. Durbin addressed the shortcomings at the Baltimore plant.
"I would say that this is another example that we do have regulations and we do have processes in place that ensure that the vaccines that are produced are high quality." That they are safe and that they will be effective in the prevention of COVID,"
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