Tag Archives: letter

FDA nails Pennsylvania generics maker with 2nd warning letter in a year

An FDA warning letter is an ignominious sign for any company and a wake-up call for change. But two warning letters in one year? That’s an alarm bell for most companies—a fact that a Pennsylvania-based drugmaker is finding out the hard way after a new FDA notice. FDA investigators accused KVK-Tech of failing to set… Read More: FDA nails Pennsylvania generics maker with 2nd warning letter in… »

Mylan West Virginia plant tagged with warning letter by FDA

The other shoe has finally dropped on Mylan’s troubled manufacturing plant in West Virginia. The drugmaker acknowledged Tuesday that the FDA this month issued a warning letter for the problems at the massive site.   Mylan in a statement said the November 9 warning letter was tied to the problems the FDA had already laid… Read More: Mylan West Virginia plant tagged with warning letter by FDA »