However, Emergent was found to have numerous quality issues at its Bayview, Maryland facility culminating in the destruction of nearly 400 million doses of vaccines, according to a US Government report. A Form 483 (notice that the facility and the process for the given product are not in compliance with cGMP law) was issued by the FDA including many severe and critical observations. Normally, such notice would require immediate stop and recall of the already shipped product. At the time, nearly 15 million vaccine doses at the site were deemed unusable. This should not surprise anyone, as Emergent is notorious for never following any pharmaceutical compliance rules. Emergent’s main business is supplying the US Government and DOD with anthrax “vaccine” and other “countermeasures” for which compliance with pharmaceutical law has been waived effectively by numerous laws, acts and administrative rule changes and, as belt-and-suspenders approach, also shielded by the PREP Act. In fact, Emergent’s own contract with the DOD for production of vaccines (countermeasures) states that if there is no current PREP Act declaration, then whatever Emergent ships or has already shipped to the government is “not for human use”.
