INTERMEDICS THIRD-PARTY CERTIFICATION OF GMP COMPLIANCE
This article was originally published in The Gray Sheet
Executive SummaryINTERMEDICS THIRD-PARTY CERTIFICATION OF GMP COMPLIANCE is under way in response to a July 27 warning letter from FDA requesting the certification. The warning letter, which followed a March 7 to April 26 inspection of the company's pacemaker manufacturing facility in Angleton, Texas, cites the company's repeated deviations from good manufacturing practice regulations.
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