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Article: St. Jude under FDA Scanner - Analyst Blog
- Article from:
- Zacks Investment Research - Analyst Blog
- Article date:
- July 6, 2009
- Author:
CopyrightCopyright 2009 Zacks Investment Research. (Hide copyright information)
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St. Jude under FDA Scanner - Analyst Blog
St. Jude Medical
(
STJ
) recently announced that two out of its 12 manufacturing facilities are presently under the FDA's (Food and Drug Administration) scrutiny as their manufacturing practices were not in conformity with the Current Good Manufacturing Practice.
The FDA has already issued a warning letter to St. Jude to state that it would neither grant the company's requests for export certificates to foreign countries, nor clear any pre-market approval applications for its class III devices until the violation is rectified.
The two facilities identified are Plano, Texas and Hackettstown, New Jersey. The company has already provided ...