Impax Laboratories Inc. (IPXL) received a U.S. Food and Drug
Administration warning letter related to its Hayward, Calif.,
manufacturing facility that led to the voluntary recall of its
generic cholesterol drug, fenofibrate.
The pharmaceutical company said the inspection, conducted
between Dec. 13 and Jan. 21, cited issues related to sampling and
testing of in-process materials and drug products, production
record review and the process for investigating the failure of
certain manufacturing batches.
Because of the FDA's initial inspection results, the company
said it conducted a voluntary recall in March of five lots of
200-milligram fenofibrate capsules at the wholesale level.
Impax said the Hayward facility's production level was reduced
during the past three months to implement several changes in its
quality system. The site is now producing product at a normal pace
and Impax doesn't plan to reduce its product manufacturing or hold
shipments of finished product.
The company has 15 business days to respond to the FDA's May 31
warning letter, which was received Friday.
"We intend to promptly respond to the FDA's letter, and have
already begun to implement changes and establish procedures that
address the observations cited during the inspection," said
President and Chief Executive Larry Hsu. "We will work diligently
to remedy any outstanding issues in a timely manner."
The company reported in May its first-quarter profit dropped 89%
as revenue fell 66%, due in part to an insufficient supply of
generic Adderall XR, an attention deficit and hyperactivity
disorder drug.
Shares closed at $25.65 on Friday and were inactive premarket.
The stock has risen 26% over the past year.
-By Melodie Warner, Dow Jones Newswires; 212-416-2283;
melodie.warner@dowjones.com