Calypte acts to comply with FDA warning letter:
This article was originally published in Clinica
Calypte Biomedical is taking action to comply with an FDA warning letter listing significant deviations from Federal regulations in the operation of its newly-acquired plant in Rockville, Maryland. The warning letter was based on inspections of the Rockville plant made in November and December 1998, when it was owned and operated by Cambridge Biotech, a subsidiary of bioMerieux Vitek. Calypte says it has responded in writing to many of points raised by the FDA and is rectifying the remaining issues.