MDS Pharma cited in FDA manufacturing letter
Executive Summary
FDA will scrutinize MDS Pharma Services' bioequivalence studies on a case-by-case basis because the company's approach to investigating contamination sources in such studies is inadequate, the agency says in an April 26 "untitled" 1letter. The enhanced scrutiny could result in "additional inspections, third-party audits, and rejection of data," the letter says. The letter follows two failed inspections...