Bristol-Myers Excedrin draws FDA warning letter for batch uniformity testing problems.
This article was originally published in The Tan Sheet
Executive Summary
EXCEDRIN EXTRA STRENGTH GMP ISSUES RESOLVED prior to the approval of Bristol-Myers Squibb's new Excedrin Migraine product. A Nov. 17 FDA warning letter was issued after an inspection of the company's Morrisville, N.C. manufacturing plant revealed product uniformity problems. The inspection was conducted in preparation for approval of the new product, which was granted marketing clearance Jan. 14 ("The Tan Sheet" Jan. 19, pp. 1-3). The company responded to the warning letter saying the issues had been addressed; a second FDA inspection confirmed this, and approval of Excedrin Migraine proceeded.