Friday, August 15, 2014

FDA raises concerns about Impax's Taiwanese plant

Tue Jul 29, 2014 9:28am EDT

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(Reuters) - Impax Laboratories Inc said the U.S. Food and Drug Administration issued certain observations regarding violations in the company's manufacturing plant in Taiwan.

Shares of Impax, which makes generics and specialty drugs to treat central nervous system disorders, fell about 17 percent to $23.15 premarket on Tuesday.

The regulator issued 10 observations in a Form 483, which is usually issued when inspectors find conditions that may violate the U.S. Food Drug and Cosmetic Act.

The FDA's investigation revealed issues including invalidated equipment used in the drug manufacturing process and a failure to reject drug products that do not conform to specifications and conduct a thorough review of failed batches.

The plant manufactures 12 products for distribution in the United States.

The regulator conducted the inspection between July 21 and July 26 to review the adequacy and accuracy of data provided in the marketing application for the company's Parkinson's disease drug, Rytary.

Impax said on Tuesday that the FDA did not specify the impact its observations will have on Rytary's Oct. 9 review date.

The company's shares have gained more than a third of their value in the past year.

(Reporting by Natalie Grover in Bangalore; Editing by Saumyadeb Chakrabarty)

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