Impax Labs Slumps After Problems with FDA Inspection

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Those included problems with equipment, sample testing, rejection of drugs that didn't meet the company's manufacturing standards, and procedures designed to keep microorganisms out of some products.
台灣 Impax 經US FDA inspection有10 "observations",  問題點大至如上 述, 請大家想想, 為何台灣Impax廠作業上會不符合company's manufacturing standards? 人員的作業發生甚麼問題?Training 不確實? or 其他?

Impax Labs Slumps After Problems with FDA Inspection

Drug Discovery&Development Wed, 07/30/2014 - 8:28am

Shares of Impax Labs sank Tuesday after an FDA inspection uncovered potential problems at a facility where the company will make its experimental Parkinson's disease drug Rytary.

Impax said the Food and Drug Administration inspected the manufacturing facility, which is in Taiwan, earlier this month. It said the agency had 10 "observations," or issues it wants Impax to address. Those included problems with equipment, sample testing, rejection of drugs that didn't meet the company's manufacturing standards, and procedures designed to keep microorganisms out of some products.

The company said it does not know if the results of the inspection will affect the FDA's review of Rytary.

Impax Laboratories Inc. stock lost $3.64, or 13 percent, to $24.39 in afternoon trading.

The Taiwanese facility makes 12 products sold in the U.S.

Impax has been unable to get marketing approval for Rytary because of problems stemming from FDA inspections. The FDA sent Impax a warning letter in January 2011 based on an inspection of the facility in Hayward, California, where Impax planned to manufacture the drug. The agency found new problems during inspections in 2012 and 2013.

The company filed for FDA approval again in April, and the FDA is scheduled to make a decision by Oct. 9.

Source:

http://www.dddmag.com/news/2014/07/impax-labs-slumps-after-problems-fda-inspection

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