The federal Food and Drug Administration has issued a warning to a Northeast Philadelphia drug manufacturer, Frontida BioPharm, over what it says are “significant violations” of “good manufacturing practices.”
Last summer, the FDA inspected the facility then owned by Sun Pharmaceuticals. Inspectors found problems including inadequate quality control that allowed the release of a potentially contaminated hypertension medicine; poor record keeping; and unsatisfactory cooperation during the inspection process.
The FDA and Sun communicated about the problems, but earlier this summer, the facility was taken over by Frontida.
Erik Gordon, a University of Michigan professor who watches the pharmaceutical industry but isn’t familiar with this case specifically, said it’s usually not a good sign that a warning letter comes after a takeover.
He said this probably isn’t “something that is momentum left from the old owner. This is something that Frontida has been in for two months, and whatever else they’ve done since taking over the plant, it has not included satisfying the FDA that progress is being made sufficiently quickly.”
A warning letter, Gordon, added is very serious.
“You get the warning letter when whoever you’re dealing with at the FDA finally shrugs, and say, ‘I’m going to get their attention,’” he said.
Last fiscal year, the FDA issued just 76 warning letters out of its drug unit.
Frontida’s response to the FDA’s concerns was due yesterday, but the FDA would not say whether the company made that deadline.