Business is booming and perhaps the plant is working near capacity...BD
An FDA inspection of Merck’s big vaccine plant in West Point, Pennsylvania found 49 “areas of concern,” the Philadelphia Inquirer’s Karl Stark reports this morning.
The agency’s report, which the Inquirer got under the Freedom of Information Act, cited issues including unwanted “fibers” on the stoppers of vials of MMR vaccine and a failure to follow good manufacturing practices.
“There are numerous issues where they failed to comply with their own documentation and SOP [standard operating procedure] requirements,” he told the paper. “Sometimes in a plant where everyone feels overburdened . . . they give up trying to do everything and just try to keep their heads above water.”