FDA Clears Impax of Issues from 2011 Warning Letter

Impax Laboratories says the FDA has inspected its Hayward, Calif., manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products.

The pipeline consists of 33 pending ANDAs, with 25 developed internally and eight developed through external partnerships, CEO and President Fred Wilkinson said.

Of the 17 ANDAs developed at the Hayward plant, two could launch later this year and eight in 2016. The applications include generics of Sanofi’s kidney disease drug Renvela (sevelamer carbonate), Daiichi Sankyo’s and Genzyme’s diabetes and cholesterol drug Welchol (colesevelam HCI), Teva’s ADHD drug Adderall XR and Purdue Pharma’s OxyContin TR.

The FDA issued the warning letter in May 2011 for manufacturing violations related to finished pharmaceuticals identified during a Dec. 13, 2010, to Jan. 21, 2011, inspection.

The inspection found deviations in sampling and testing of in-process materials and drug products and lapses in production record reviews. For example, Impax couldn’t demonstrate that the manufacturing process for fenofibrate capsules was capable of controlling weight variations and didn’t have data to support the temperature range used during the granulation process of colestipol hydrochloride tablets, according to the warning letter.

The letter followed a Form 483 that triggered a voluntary recall of fenofibrate capsules in March 2011.

Wilkinson did not say how the company resolved the items in the warning letter.

Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.