Momenta Pharmaceuticals Inc. Message Board

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Biotech / Medical : Momenta Pharmaceuticals Inc.

MNTA 52.48

0.0%

Oct 2 5:00 PM EST

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From: Ian@SI	2/3/2011 6:23:06 PM
	Read Replies (1) of 3027

Not that I'd wish them any trouble... ;) 6:45AM Teva Pharma discloses warning letter from the U.S. Food and Drug Administration (TEVA) 55.38 : The warning letter is connected with an FDA current Good Manufacturing Practices (cGMP) inspection of the Company's Jerusalem Oral Solid Dosage manufacturing facility, which took place in September 2010. At the conclusion of that inspection, the FDA issued Form 483 Inspectional Observations, to which the Company responded in October 2010. FDA cites cGMP deficiencies related to laboratory reporting and systems. The Company believes that, since its initial written response sent to the FDA in October 2010, it has addressed the Form 483 observations, and is working diligently to resolve any outstanding FDA concerns listed in the warning letter. The warning letter does not restrict production or shipment of the Company's products from this OSD facility. However, unless and until the Company is able to correct outstanding issues to the FDA's satisfaction, the FDA may withhold approval of pending drug applications listing the Jerusalem OSD facility. The FDA may also withhold permission to export products manufactured at the facility into the United States.

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