FDA finds manufacturing issues at Impax's Hayward, Calif., plant
HAYWARD, Calif. — The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.
Impax said it received a warning letter from the FDA on Tuesday in which the agency said it found “deviations” from current good manufacturing practice, or cGMP, for finished pharmaceutical drugs, related to plant inspections that took place between Dec. 13, 2010 and Jan. 21, 2011. The company said the deviations were found in sampling and testing of in-process materials and drugs, production record review and investigation processes for the failure of certain manufacturing batches to meet specifications. Initial results led to a voluntary recall in March of fenofibrate capsules in the 200-mg strength at the wholesale level; fenofibrate is used to lower cholesterol and triglycerides in the blood.
Impax said the problems only were at the Hayward, Calif., plant.