“CDC made its test in one of its laboratories, rather than in its manufacturing facilities,” the FDA spokesperson told CNN on Saturday. “CDC did not manufacture its test consistent with its own protocol.”
The government has never fully explained what stalled the rollout of a crucial test needed to begin measuring the extent of the spread of Covid-19. It would take until the end of February to correct and the US continues to lack extensive testing capability even as some states prepare ease up on restriction and reopen to a degree…
On February 22, an FDA official traveled to Atlanta and spent the following days visiting CDC labs to try to sort out the testing problem.
According to an administration official, the FDA determined contamination was most likely occurring during the manufacturing process and that the CDC had appeared to have violated its own manufacturing protocols.