Elkins-Sinn GMP deviations in injectables manufacturing, packaging result in FDA warning letter.
Executive Summary
ELKINS-SINN GMP DEVIATIONS FOR INJECTABLES RESULT IN WARNING LETTER from FDA July 14 citing 10 violations of current Good Manufacturing Practices at the Wyeth-Ayerst injectable drugs manufacturing facilities in Cherry Hill, N.J. FDA inspectors were on site at the facilities March 30 for a pre-approval inspection. Based on the warning letter, inspectors continued to evaluate the facilities on site at least until May 4.