Whistleblower raises hygiene concerns from 2018 FDA inspection of Merck's Durham plant
Zachery Eanes, The News & Observer (Raleigh, N.C.)
Apr. 2—DURHAM — Inspection officials from the U.S. Food and Drug Administration improperly downgraded hygiene concerns in 2018 at Merck's Durham facility — a vaccine manufacturing plant that stands to play a key role in producing Johnson & Johnson's one-shot COVID-19 vaccines, according to a complaint filed by an FDA whistleblower.
The whistleblower, a former FDA safety officer, wrote that he came away with serious public health concerns after touring Merck's facility in 2018, noting that the Durham plant "produces vaccines for some of the most vulnerable populations."