Action Plan
FDA inspection results still unknown
Published in Medical Letter on the CDC and FDA, November 3rd, 2002
The results of the inspection were not known at the time. The FDA recently issued a reinspection report. Based on the company's initial assessment of the report, the company believes that the remedial action plan put in place following the September 2001 inspection must be expanded in scope and extended in duration and certain other actions may need to be taken to comply with FDA regulations.
Until the company fully formulates its revised...
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