A new FDA report says Novartis was slow to address problems at its Lincoln, Neb., manufacturing plant.
The Jan. 20 inspection report may also shed light on why Novartis temporarily closed the plant in December and recalled several of its over-the-counter drugs last month, including Excedrin, NoDoz and Gas-X.
The FDA inspectors say six of the 10 problems they found in December were repeat offenses initially discovered last July. For
instance, the FDA says Novartis was overdue in responding to nearly
1,400 consumer complaints.
Some of the complaints sound similar to the reason for the recall because consumers had reported finding foreign tablets or objects in the product.
Novartis officials say the plant was shut down for maintenance, not because of the FDA inspection.