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The QMN Weekly Bulletin
July 1, 2011 | Vol. 3 No. 26
FDA Cites Medrad in Warning for Failure to File Corrections Report
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.
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