FDA Cites Medrad in Warning for Failure to File Corrections Report

July 1, 2011
The FDA has warned Medrad saying there is no evidence the company submitted a correction and removal report for several corrections to a product. During an FDA inspection of the company’s Indianola, Pa., facility, the agency found Medrad received 45 reports of alleged air injections during procedures using its Avanta fluid management injection system.
The GMP Letter