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Searle Norpace investigation of stability test failure cited in FDA warning letter.

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Executive Summary

SEARLE NORPACE INVESTIGATION OF STABILITY TEST FAILURE CITED in an FDA warning letter sent to the company on Jan. 31. During an Oct. 8 to Dec. 12 inspection of Searle's Caguas, P.R. drug manufacturing facility, FDA investigators recorded dissolution testing failure for stability samples of one lot of Norpace (disopyramide phosphate) controlled release capsules and found that the company's investigation of the failure was inadequate.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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